We’ve been wanting to have a conversation about the benefits of bringing Quality in earlier for a long time.

While we see some teams make progress here, it’s still the case that by the time QA is consulted, many technical decisions have already been made. The capital is committed, the headcount is set, and investor expectations are locked. So when a problem surfaces, the question isn’t whether to fix it — it’s how expensive the fix has to be.

That’s the argument Dr. Andrea Bell makes, and her framing is sharper than the usual case for involving Quality sooner. She argues (and we agree) that late QA involvement doesn’t just add cost. It removes the option to remediate cheaply, which is the whole premise behind right-the-first-time. We see teams find this out the hard way more often than we'd like.

Nick Capman sat down with Andrea to talk about moving QA from late-stage gatekeeper into an early, risk-appropriate technical partner.

Andrea is a biotech executive with more than 25 years of experience leading Quality and CMC organizations across biologics, RNA therapeutics, vaccines, and small molecules. She currently serves as a Vice President of Global Quality.

Throughout her career, she’s been recognized for building high-performing teams, developing fit-for-purpose organizations and quality systems, and driving complex programs from early development through commercialization, helping bring innovative therapies to patients worldwide.

She holds a doctorate in Global Health Sciences, a master’s degree in Quality Assurance and Regulatory Affairs, an MBA in International Business, and is passionate about advancing global access to transformative medicines.

She was also candid about why the topic matters to her. She’s worked on both sides of the divide, in organizations where Quality wasn’t consulted early or empowered to act, and in companies where Quality was built in as a partner from the start. So rather than the typical theory, she speaks to what she’s actually seen work (and fail).

The views expressed in this conversation are Andrea's own and do not represent the position or views of her employer.

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Andrea’s key insights and practical takeaways

If you’re short on time, here are the most important lessons from the discussion.

Late QA involvement removes your cheap options. This is the core of it! When QA sits organizationally downstream and isn’t consulted until after technical decisions are made, the costs land after the company has already committed capital, headcount, and investor expectations. At that point, you can still fix the problem. You just can’t fix it inexpensively.

Most of the cost of poor quality sits below the waterline. Andrea referenced the FDA’s iceberg model. Above the line are the direct costs everyone counts: recalls, lost revenue, legal and regulatory expenses. Below it lies the larger, less visible aggregate, including scrap rates, cycle-time delays, market share loss, costly investigations, and reputational damage that can take years to repair or may never fully recover. Those eventually show up in stock performance!

A single 483 carries a real remediation cost before you count the opportunity cost. Andrea cited a range of roughly $250,000 to $5 million in direct remediation for one 483 and noted that the figure excludes delayed clinical timelines and stalled BLAs. Both of those affect patient access.

Early means early in the conversation, not just early in the lifecycle. This distinction is easy to miss. Andrea’s point is that “early” also applies to the decision forums that occur at every phase: design-of-experiments reviews, tech transfer meetings, and the discussions where the technical calls are actually made. Being invited to those is different from being involved early in a general sense.

ICH Q8 grounds the argument. Quality target product profiles and critical quality attributes should be defined before process development begins. Having QA at the table when those are defined, rather than reviewing them afterward, is where the value shows up.

What this looks like across the lifecycle. Andrea walked through it phase by phase. In R&D and discovery, through first GMP, QA joins cell line, cell bank, and asset qualification discussions as they happen, with systems staying fit for purpose and a focus on traceability and data integrity.

• In Phases 1 and 2, QA reviews the design of experiments alongside process scientists so critical process parameters get identified upfront rather than reverse-engineered after a deviation.

• In late Phase 3 and pivotal work, QA shifts toward process lockdown support, and the CPPs, CQAs, and control strategy get finalized there rather than under filing pressure or in response to agency questions.

• At the NDA and BLA stages, validation is already complete, so PPQ confirms a known relationship rather than discovering one, and QA moves from inspection to inspection readiness by stress-testing systems before the PAI.

• Post-launch, QA stays in the continuous process verification loop with change control and real-world manufacturing knowledge feeding back into the program.

Risk-based doesn’t mean less rigorous. It means rigor pointed where the risk is. ICH Q9 frames this around two principles: risk evaluation grounded in scientific knowledge and tied to patient protection, and effort, formality, and documentation commensurate with risk rather than maximal by default. Andrea’s read is that applying commercial-level scrutiny at Phase 1 doesn’t make you safer. It misallocates resources away from where the actual risk sits.

The rigor doesn’t loosen; it strengthens! You still identify hazards, analyze and evaluate risk, and put controls in place, using tools like FMEA systematically. What you gain is a defensible reason behind every decision, which is what agencies are looking for. A uniform checklist applied across the board is a weaker position, and agencies will challenge it.

Three questions focus the risk analysis. Is there an impact on the patient, the product, or the process? Andrea uses that frame during Phase 1 and 2 technical evaluations to keep attention where it belongs.

The barriers are cultural, not procedural. This is the part most organizations get wrong. The obstacles to embedding QA earlier are usually a lack of a quality culture and a reporting structure, along with a genuine misunderstanding of QA’s responsibilities. A QA function only involved in late development can often measure nothing but deviation closure rates, which pushes it into a reactive mode no matter how capable the people are.

Three concrete moves leaders can make. Give quality standing membership in the technical forums. Run a formal maturity assessment to establish a baseline worth tracking against, using ISPE’s Advancing Pharmaceutical Quality program or PDA’s quality culture assessment tool. And commit at the leadership level, which ICH Q10 identifies as foundational, meaning resources are committed and quality is genuinely empowered.

Culture follows what leadership measures and rewards. Andrea’s observation from culture survey data. If leadership doesn’t empower Quality and doesn’t reward behaviors that support patient safety, the organization won’t produce it, regardless of what the procedures say.

The Q8, Q9, Q10 trifecta is the operating framework. Q8 defines quality through QTPPs and CQAs. Q9 supplies risk prioritization methods and the tools for determining critical process parameters and controls. Q10 provides the pharmaceutical quality system lifecycle that carries those decisions forward. Newer capabilities, such as real-time release testing and process analytical technology, build on that foundation by generating data during the process rather than only at batch record review.

Data makes QA proactive only if people are empowered to act on it. Both halves are required. Andrea framed the quality management review as where this gets tested, and a functioning one does three things: it surfaces metrics that can be acted on rather than burying them in a report nobody reads until the next audit, it escalates when a threshold is breached instead of waiting for the next scheduled review, and it carries real authority.

Recurring unresolved issues in the QMR cycle are visible to agencies. Andrea was pointed here. Where health authorities have issued 483s or provided feedback, a pattern of issues recurring quarter after quarter without resolution signals either that they aren’t receiving attention or that leadership isn’t empowered. Raising the issue isn’t enough. Showing the data isn’t enough! State of control means acting in real time rather than batching problems downstream, where they compound and sometimes become unsolvable.

QA earns credibility by changing what it brings, not just when it shows up. The gatekeeper posture is arriving to say no. The partner posture is to sit with the technical team, ask what could go wrong and how bad it would be, then work on the problem together. Andrea’s framing is that QA becomes a co-author of the argument you’ll eventually make to the regulator, not the signature at the end.

Regulations are open to interpretation, and agencies want to see your logic. This is the nuance underneath the credibility question. Any regulation means something slightly different in the context of a specific company and program. Regulators want to see a consistent rationale and sound scientific logic behind a decision, rather than evidence that a box was checked. QA’s combination of regulatory knowledge and technical understanding is exactly what produces that.

The three-batch example shows where credibility actually comes from. Three consecutive validation batches became standard industry practice, and Andrea’s question is where that number came from. FDA guidance has moved away from prescribing it. Now you justify your number based on risk and process understanding. Put three down, and you should expect to be asked why three. Three may be too few, or a statistically justified alternative may be more defensible for your situation. Helping build that logic early is where QA earns its seat, not by enforcing a rule.

What to develop if you want to do this work. Andrea’s list starts with genuine curiosity, an open mind, and the soft skills that show up as “how” rather than “no.” Then scientific fluency, real operational knowledge of what you’re overseeing, statistical and risk analysis literacy, working knowledge of the ICH guidelines and tools like FMEA, and data and digital fluency, including how AI-driven tools can be leveraged, how they need to be validated, and what proper quality oversight of them looks like. Together, those build the trust that gets QA invited to the table.

Design governance so early involvement is the path of least resistance. ICH Q10 already lays out the pharmaceutical quality system lifecycle. Instead of a single late-stage gate, build phase-appropriate risk and analytical checkpoints into the process as programs mature. Practically, that means standing membership in technical discussions rather than only change review boards, explicit decision rights, and scoping the risk level up front. The goal is not an approval step bolted on top. It’s making the earliest possible involvement the easiest thing to do.

Three steps to start tomorrow.

1. Run a baseline quality culture maturity assessment using ISPE’s APQ or PDA’s tool, so you understand where quality actually sits in your development timeline based on evidence rather than anecdote.

2. Pilot the technical partnership model on a single active program, putting QA in the room for QTPP and CQA definition and DOE planning, and running FMEA jointly with the technical team.

3. Then establish QMR metrics with real leadership commitment, using FDA’s voluntary Quality Management Maturity program, and supplement deviation closure counts with leading indicators like right first time, cost of poor quality, cycle time, and root cause closure.

Andrea E. Bell, DHS, MS, MBA, is a Vice President and Global Head of Quality Assurance with more than 25 years in biotechnology, focusing on harmonization, phase-appropriate quality systems, and quality risk management. She’s built quality and CMC organizations across RNA, biologics, and small-molecule programs and has led complex programs from early development through commercialization. She holds a doctorate in global public health with a focus on vaccines from Massachusetts College of Pharmacy and Health Sciences, a master's in quality assurance and regulatory affairs from Temple University, an MBA in international business, and a bachelor's in biology.

Connect with Andrea on LinkedIn here.

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Check out our newly launched AI-powered QMS audit tool, AICA (the Audit Intelligence Compliance Assistant).

Andrea and Nick get into the real cost of late QA involvement, how risk-based rigor differs from uniform rigor, what makes a quality management review actually function, and how QA earns credibility with technical teams.

A few of Andrea's key takeaways:

• Late QA involvement costs money and removes the option to remediate cheaply

• Most of the cost of poor quality sits below the waterline in scrap, cycle time, investigations, and reputation

• Early means early in the decision forums, not just early in the lifecycle

• Risk-based rigor isn't looser rigor. Uniform checklists are a weaker position and agencies will challenge them

• The barriers to embedding QA earlier are quality culture and reporting structure, not procedure

• Data only makes QA proactive if people are empowered to act on it

• QA earns credibility by co-authoring the argument you'll make to the regulator, not by signing off at the end

About Andrea Bell

Andrea Bell is Vice President, Global Head of Quality Assurance for BioNTainer at BioNTech SE, with more than 25 years in biotechnology building quality and CMC organizations across RNA, biologics, and small molecule programs. She previously held leadership roles at Vir Biotechnology, Alnylam Pharmaceuticals, and Biogen. She holds a doctorate in global public health, a master's in quality assurance and regulatory affairs, an MBA in international business, and a bachelor's in biology.

About The FDA Group

The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

We’ve been asked how our AI-powered compliance auditing tool, AICA, compares with the AI tools the FDA has rolled out. So we wanted to break it down here because there’s quite a bit of daylight between these, even though they may soon serve common purposes.

Back in May, the FDA announced two things at once. The first was Elsa 4.0, an upgrade to the internal AI tool it launched in June 2025. The second was HALO, a platform that the agency says consolidates more than 40 of its application and submission data sources, systems, and portals into one place. (Think of it like the data layer for Elsa.)

That same day, then-Commissioner Marty Makary announced a pilot of one-day inspectional assessments for facilities that AI has flagged as lower risk.

Again, because we’re busy implementing an AI compliance auditing tool across industry RA/QA teams, we're asked whether these are the same kind of thing. Mostly, they are not — at least if and until the FDA starts using its tools the way industry teams are using ours.

Let’s briefly look at what each one does, where the two worlds touch and don’t, etc.

What the FDA actually announced about its AI tools

Let’s start with Elsa, the FDA’s internal generative AI tool that helps staff members quickly read, write, summarize, and review large volumes of scientific and regulatory data (among other things).

According to the agency’s recent announcements, Elsa 4.0 is available to all FDA staff, from scientific reviewers to investigators. The new features the FDA listed include:

The FDA says Elsa runs in a FedRAMP High Google Cloud Platform environment, does not train on input data or on data submitted by regulated industry, and isn’t connected to the open internet. The agency also states that staff verify inputs, analytical processes, and the use of outputs.

Now let’s move to HALO.

HALO stands for Harmonized AI & Lifecycle Operations for Data. According to the FDA, it’s not an analysis tool. It’s like the plumbing underneath Elsa, consolidating more than 40 disparate application and submission data sources, systems, and portals across all FDA centers into a single platform.

Chief AI Officer Jeremy Walsh described the shift in the agency’s press release: staff used to bring data to Elsa, and now, in his words, “Elsa sits on top of our data.”

So, again, you can think of HALO as the storage layer. At the Food and Drug Law Institute annual conference, acting CIO Sridhar Mantha told attendees that HALO is a single platform with the agency’s highest security level and that data inside it is compartmentalized and segmented by center, according to RAPS.

It’s worth remembering what the FDA said Elsa was for at launch (presumably, HALO helps on the data side now). The June 2025 press release listed accelerating clinical protocol reviews, shortening scientific evaluations, and identifying high-priority inspection targets.

Three tools, three somewhat different jobs

Now let’s pick these tools apart to show that they’re doing different things.

The users do not overlap, nor does the data. Nobody at a pharma company will open Elsa themselves, and nobody at the FDA is running AICA. Elsa and HALO work on material that has already been submitted to the agency. AICA works on material a company has written for its own QMS.

So a word to the wise: if you encounter anyone framing these as competing products, they’re wrong (and probably trying to sell you something).

Where they actually touch

The point of connection between these systems is, at least for now, inspection targeting, broadly speaking.

The FDA’s one-day inspectional assessment pilot began internally in April 2026 and was publicly announced on May 6. The FDA says facilities are selected using risk-based criteria including product type, prior inspection outcomes, and operational characteristics. That appears to mean they’re having Elsa ingest company data to determine who they should prioritize for inspections.

As of late April, the FDA said it had completed roughly 46 assessments, most of which resulted in “No Action Indicated” outcomes. Some ran longer than a day when investigators found significant observations. The agency was explicit that these do not replace standard inspections and are not intended for higher-risk or complex facilities. Makary described the AI’s role plainly at FDLI, saying the tool identifies which facilities are low risk.

At the same conference, Steven Musser, associate commissioner for human food research, was asked whether AI is used in inspections. His answer, as reported by RAPS, was that he does not currently see how an investigator would integrate AI during an inspection itself. What AI is good at, he said, is detecting anomalous patterns, and he pointed to a shrimp pilot program aimed at spotting adulteration and fraud.

So the honest version of the current use case seems to be quite narrow. The FDA’s AI, based on official indications, is not inspecting anyone. It’s helping decide where investigators go and how much time an establishment warrants. Skadden’s write-up of the FDLI meeting drew the practical conclusion for industry that we agree with: companies should expect AI to be applied to their submissions and should run their own analysis on material before filing.

That, at least at the moment, is the closest thing to a real link between what the FDA built and what AICA is doing inside RA/QA teams. It’s a link about sequence, not about function.

In case you haven’t seen our AICA demo, it puts a finer point on what that system can do and who it’s for:

Some more nuances

Musser named a limitation at FDLI that seems to apply to every tool in this category, including ours with AICA.

The AI powering these systems reports what the literature says without weighing the methodological quality of the sources. It can tell you that 100 papers reached one conclusion and 3 reached another, without assessing which studies were better designed. He also noted that outputs vary across queries, raising questions about reproducibility.

The equivalent limitation for AICA is worth stating here. It compares what a procedure says against what a regulation requires. It does not judge whether a procedure is well designed for a particular operation, whether anyone follows it, or whether the batch records support it. That requires context and human interpretation that simply can’t be ingested into the system.

Documentation review is part of a broader program that also covers implementation, quality records, personnel interviews, and facility observation. AICA also does not (at the moment) audit against a company’s internal standards, only against regulatory requirements.

What a former FDA enforcement director expects next

David Elder spent 23 years at the FDA, including serving as director of the Office of Enforcement and the Office of Regional Operations, and earlier as an investigator and compliance officer.

In a June 8, 2026 guest column for Pharmaceutical Online, he wrote that the FDA has begun using AI both before and during certain inspections and remote regulatory assessments, and described Elsa as supporting the thoroughness and efficiency of inspections by analyzing and comparing information from multiple sources.

The sourcing and wording here matter.

Elder states this as current practice. The FDA has not said it publicly, and the footnote he attaches to that section points to the Investigations Operations Manual and two compliance programs rather than to any agency statement about Elsa itself. So what you have is a well-placed former official describing something the agency, at least from what we can tell, has not described in an announcement attached to its tool. That deserves to be taken seriously, but carefully.

The remainder of his piece is forward-looking, and he labels it that way. He lists the company data he expects investigators would feed such a tool: complaint databases, deviation and out-of-specification investigations, change control records, CAPA data, risk management files such as FMEAs, and key SOPs and work instructions.

He pairs that with FDA-held data, including adverse event systems, Field Alert Reports, the Recall Enterprise System, and prior inspection records. His sample queries carry a note that they are illustrative of the thinking only, and he calls the practice currently in its infancy.

The takeaway for an RA/QA team

The comparison we’re sometimes asked for, “whose AI is better,” does not exist because the tools are not doing the same work.

No hard evidence or announcements establish that the FDA is running QMS documentation through Elsa today. The FDA has confirmed using Elsa for inspection targeting, among other things. A former enforcement director describes more than that and does not cite an agency statement to support it. A few unverified accounts we’ve heard describe more still. Those are different levels of evidence, and collapsing them into a single claim is how an industry talks itself into a panic.

What they share is a direction. The FDA has spent a year making its own data faster to query, and it has started using that capability to decide where investigators spend their time. Whether that capability eventually points at company records during an inspection is a question no one outside the agency can answer right now.

Which is why the case for running your own analysis first does not depend on the strongest version of the story being true. If the FDA never goes beyond targeting, a company still benefits from knowing where its written system is thin before it lands on a target list. If Elder is right about where this goes, the same work matters more and needs to extend past procedures into quality data. Either way, the homework is the same, and it is homework a company can do without waiting to find out which version is correct.

We built AICA to give industry teams the compliance audit tooling that we’d expect the FDA to use itself at some point. The teams we’re onboarding now want to be ahead of the game.

Have questions or want to get a demo?

Want to see whether AICA fits your team? Visit aica.thefdagroup.com to learn more and get in touch. You can also email Eric directly at eboyd@thefdagroup.com and let him know you’d like to set something up. We’re onboarding teams to the tool right now.

We recently published our comprehensive guide to annual audit planning. This is the compressed companion version: seven things to do this quarter to prep for next year if you haven’t solidified your plan yet.

As we noted in our other guide, the reason we push teams to kick off next year’s audit planning in Q3 comes down to the calendar math. If your first 2027 audits are in January, agendas are drafted and approved in Q4, when approvals are slow and many sites are closed. That means everything January depends on gets decided in October, which makes September the last real month to do the thinking.

Each item below has a “done when” so you can tell whether you’ve actually finished it or just feel like you have.

Download our free Excel audit planning workbook if you haven’t already:

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1. Reconcile your audit universe for next year

First things first: pull every auditable relationship or other auditing need into a single list before you decide anything. Your approved supplier list, your quality agreement register, CMO and CRO contracts, contract labs, your internal sites, and last year’s audit schedule and reports.

If you run clinical programs, add TMF and eClinical vendors.

You might find that some sources “agree” with each other. That could be a supplier on the ASL with no quality agreement. You might have quality agreements for suppliers nobody has audited in years. Or you might have added vendors mid-year that never made it onto a schedule.

Each of those is a purchasing control or supplier evaluation observation sitting in plain sight, and finding them in August or September is a much better experience than finding them during an inspection.

2. Close out this year before you start planning next year

Two things to figure out now rather than in December.

• First, which of this year’s audits are going to slip into next year? An audit that slides from Q4 2026 into Q1 2027 doesn’t disappear. It lands on top of a quarter you’ve already committed, and Q1 is the quarter with the least room in it. Better to know in August that you’re carrying three audits forward.

• Second, are the CAPAs from your last round of audits actually verified as closed? An open CAPA that nobody has verified is a finding in itself, and it’s also a reason to put that supplier back on the 2027 list, regardless of where their interval sits.

3. Classify by risk and write down the reason

We usually suggest applying your normal audit intervals first. Anything whose audit frequency comes due in 2027 goes on the list.

Then apply the things that override the interval. A few common ones include:

• Quality events traceable to a supplier

• A change in ownership, site, process, or where a material is made

• New material, expanded scope, or first commercial supply

• Regulatory action against them.

• Open CAPAs

• No audit on record at all

Then (and this is the part people skip), put the reason next to each line. Not a category code! A short sentence a stranger could read. That column is the written record of your risk-based decision, and it’s what someone will ask about when they want to know why the supplier behind your last three deviations wasn’t on the schedule.

4. Decide what you’re not auditing, and get it on the record

A lot of programs have more candidates than budget. The deferral is a decision whether you make it or not. The question is whether you make it in September, deliberately, with a reason, or in March, by running out of time.

A simple way to do this is to go through your suppliers that didn’t make the 2027 list and note why. Low criticality? Audited recently with no findings? Questionnaire in lieu of an on-site? No material change since last time?

And if the answer for some of them is budget, write that down too, because that belongs in a management review conversation rather than a scheduling one.

5. If you need to, get a number in front of finance while the budget is still being built

August through October is when most companies are building next year’s budget. That’s the window where an audit program is a line item. By November, it’s often an exception request, and exception requests get trimmed.

Rough math is fine at this stage for many of the teams we work with. Total audit days times a blended day rate, plus an average travel figure per on-site audit.

6. Refresh your site contacts and read your quality agreements

Quality staff obviously turn over like any other department, and the contact who hosted an audit back in 2025 has a decent chance of being gone. Confirm you have the person who can actually approve an audit date, not the commercial contact. Name, title, direct phone, email, time zone. Note the working language and whether an interpreter will be needed, as this affects who can conduct the audit.

While you’re in the file, check what the quality agreement says about audit rights, how many audit days you’re entitled to per year, and the notice period. Some agreements we’ve seen require 60 or 90 days of notice, which quietly rules out Q1 for anything you haven’t already asked for.

7. Name the auditors you want back, and start the conversation

If you ran audits this year, pull the auditors' names from those reports and add them to the schedule. Then decide line by line: retain the same person, rotate someone new in, or leave it open and let availability, location, and cost decide.

There’s no universal right answer on retention. Continuity means the auditor already knows the site, the systems, and what was left open last time. Rotation means someone asks the questions the returning auditor stopped asking. Both are defensible under the right circumstances.

What isn’t really defensible is deciding in January, because by then the auditors you had in mind are usually committed. This is the one item on this list with a hard external deadline attached, and it’s the reason we push clients toward October rather than year-end.

If you’d rather not run this alone

Send us the list, and we’ll take it from there! One proposal can cover your whole program if you prefer — however, many audits are on it, and you can add to it or drop from it as your risk assessment moves through the year.

How much of the running we do is your call. We can contact the sites, negotiate and confirm dates, build and circulate agendas, manage CV review and approval, run the audits, and keep the master schedule current. Or you can keep the site relationships, and we can work through you on availability and scheduling.

Our auditors are former FDA investigators and industry quality professionals, we cover GMP, GCP, GLP, GCLP, CSV, pharmacovigilance, and quality system audits worldwide, and every engagement carries our Total Quality Guarantee.

If we ran your audits in 2026, contact your project manager, and we’ll hand your own data back to you, so you’re marking up last year’s list instead of starting from a blank sheet. If you haven’t worked with us before, get in touch and tell us roughly what you’re planning. A rough audit count, the GxP mix, and the geographies are enough for us to tell you what’s realistic. We respond within one business day.

You don’t need all seven of these finished to start the conversation. But you do want them finished before October.

Get in touch with us

We’ve had quite a few conversations about everything auditing. Check them out if you haven’t already:

Thermo Fisher Scientific’s Director of Corporate Quality, David Festa, gives some advice on approaching supplier audits:

NubGenix’s Founder and CEO, Divya Gowdar, discusses the pitfalls and lessons learned on the front lines of audit and inspection readiness throughout the FDA-regulated industries:

And it’s an oldie, but a goodie, our conversation about the ins and outs of FDA PAIs with former FDA investigator, Chris Smith:

Who is The FDA Group?

The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on Quality Assurance, Regulatory Affairs, and Clinical Operations.

With thousands of resources worldwide, hundreds of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee. Learn more and schedule a call with us to see if we’re a fit to help you access specialized professionals and execute your projects on time and on budget.

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Jessica Smith has a PhD in bioengineering, 25 years in medtech, and a career that spanned executive regulatory and quality roles at some of the largest device companies in the industry. That's what goes on the resume, and that's what she'd talk about in an interview.

But it isn’t what shaped how she leads.

Nick Capman recently sat down with Jessica to talk about how life experiences form a leader long before anyone hands them the title. She was direct about why she wanted the conversation: she spent years making her life look less chaotic than it was, and she’s come to think the chaos is the part worth talking about.

Jessica recently retired from her role as Corporate Vice President of Global Quality and Chief Regulatory Officer at Integra LifeSciences. Before that, she held vice president roles in regulatory affairs at Hillrom, BD, and C.R. Bard, and ran her own regulatory consultancy for years alongside her corporate work.

She holds a PhD and a master’s in bioengineering from the University of Utah, an undergraduate degree in civil engineering, and a Regulatory Affairs Certification.

She was also a gymnast for seventeen years, a full-scholarship athlete at the University of Utah, a captain of an NCAA national championship team, and a two-time All-American. That part shows up in her leadership more than anything else on the list.

Jessica’s key insights from the discussion

The things that shaped how you lead don’t go on your resume. Jessica opened with this critical distinction. The degrees, the titles, the championships — those are what she’d discuss in an interview. What determines how she thinks, how she responds, and what she does under pressure comes from somewhere else entirely. Her hope for the conversation was that people would reflect on their own experiences and what those built in them, whether or not they currently hold a leadership title.

Adversity in childhood builds resilience, but only if you decide not to be a victim. By the time Jessica left for college at seventeen, she had moved fourteen or fifteen times (depending on how you count them). There was financial insecurity, housing insecurity, and food insecurity. As a child, you don’t get a vote in any of it, and she describes developing thick skin, the ability to adapt to constant change, and an early understanding that some things are simply outside your control. What determines whether you thrive or become a victim is how you respond to them.

It forces independence long before adulthood. She had to take on adult responsibilities early, including managing finances and finding her own way to gymnastics practice when nobody could drive her. She could have quit because it was too hard. She found ways instead, and that pattern of finding a way became the habit.

Bouncing back isn’t the goal. Bouncing forward is. Jessica referenced the research on anti-fragility, and the distinction matters to her. Returning to the status quo after something knocks you down is survival. Finding a way to be better on the other side of it is different, and it’s the practical definition she gives to resilience.

Community shows up for you, and it changes what you do later. When her family couldn’t afford her sport and couldn’t get her there, other families did. They didn’t have to. Jessica says that experience is why giving back is now central to how she operates, and she didn’t recognize the influence until much later.

Curiosity was celebrated at home, and it stuck. Her grandfather was an inventor, and she spent a lot of time living with her grandparents. The household was eclectic and loving, and the more different, more interesting, and more curious you were, the more it was celebrated. She ended up in regulatory affairs, which runs on rules, and she credits that upbringing with teaching her to think differently and to be brave about doing something that hasn’t been done before. Nick’s observation: you can’t think outside the box unless there’s a box, and rules and regulations are what create one.

Humor is a tool, not a distraction. Her gymnastics coach used humor constantly during training when athletes were tired, injured, or scared, and it taught her something she still uses. When she’s dealing with warning letters or serious compliance issues, finding a way to lighten the mood lets everyone take a breath and remember they’re in it together. Nick added why it works: in a difficult situation your field of vision narrows until you lose all periphery. Humor resets the frame and opens it back up.

Asking beats telling. Her college coach ran meetings before, during, and after the season where he asked each athlete a single question: what is your plan to help this team succeed? They brought a plan covering skills, grades, and how they’d support the team, and he held them to it. He had input, but the psychology of being asked rather than told changes everything. Jessica took personal accountability from that and it became central to how she leads. If you say you’re going to do something, do it. If you aren’t going to, that’s fine, but be clear before it doesn’t happen, and come with the reason and the new plan.

Failure is a rep, not an event. Jessica did gymnastics six days a week, four to six hours a day, from roughly eighth grade through high school. On the balance beam, she fell dozens of times a day and hundreds of thousands of times over the years. Any single one of those was a moment she could have decided not to get back on. She also lost far more competitions than she won. Failing repeatedly in a controlled environment teaches your body and mind to adjust, because repetition shows you every possible way something can go wrong and how to correct it.

Disappointment builds empathy, and empathy changes how you manage. Jessica was candid about the adversity in her adult life as well, including a marriage that ended, becoming a single parent, and the loss of her daughter. What she takes from it professionally is that she used to skim past people’s life experiences because they were at work. She doesn’t anymore. People bring those things with them, and leaders have to want to understand them, accept them, and make space for them rather than setting unreasonable expectations. Her experience is that when you give someone room to grieve or manage their own situation, they come back stronger, they trust you more, and they work harder because you gave them that time.

Being laid off opened doors she hadn’t considered. She was laid off from a job, got home, and thought about what had just opened up. Within a day, she called a friend running STEM programs in a government office and asked to be an intern. She credits her upbringing for that response. Having cleaned houses, pools, and laundromats alongside her mother as a kid, she wasn’t afraid to take something several levels below where she’d been. The doors are only there if you’re willing to look.

Owning a loss is what makes it fixable. Her sophomore year at Utah, on the winningest program in the country, the team finished fifth. The press wrote them off. What the team did next is the part Jessica carries into professional settings: they owned it. They accepted it, took accountability, and named what had actually gone wrong, coaches included. Everyone aligned on the goal, including athletes who wouldn’t compete but still had a role. They won the next year. Her point about work is that people so often dance around the real issue that the solutions they build fix something else. Own the actual problem and the solutions start pointing at it.

A warning letter is a blip, not the sky falling. That fifth-place season is her reference point when a company panics. This is recoverable. There’s a path. That perspective is hard to hold in the moment and it’s most of what a leader contributes.

Bravery means acting before you know it will work. Jessica describes deciding to return to finish her PhD after a ten-year break, as a single parent and sole source of income, as jumping off a cliff. She didn’t know she’d succeed and the consequences of failing were real. What she drew on was trust in herself built from earlier experiences. She defines brave leadership as being confident enough to lead people down a path you aren’t certain about, knowing you can adjust as you go. Nick’s addition, which he offers to parents: you can’t be brave unless you’re scared. People who aren’t scared aren’t being brave, they’re just doing what they do.

Imposter syndrome and not knowing yet are two different things. Jessica separated them carefully. Growing up without a car that worked, without a family vacation, without any model for the professional world she ended up in, she experienced a version of feeling out of place that came from unfamiliarity rather than inadequacy. There’s also a healthy acknowledgment that you haven’t done something before and don’t know if you can. And there’s genuine imposter syndrome, which she felt going back for her PhD with no one in her family having done it and no example to follow. Knowing which one you’re experiencing is hard and worth the effort.

Sometimes the room is telling you something about the room. She’s been on leadership teams of eighteen where she was the only woman. Part of that feeling is personal, and part of it is a signal that building the right diversity of skills and perspectives takes conscious effort rather than happening on its own.

Understand how far the fall was. Nick raised this, and Jessica found it worth sitting with. Supporting someone on the way up is easy. The harder work is supporting them through a fall, and doing that well requires understanding what the loss actually meant to that specific person. Two people can experience the same setback very differently depending on what they had and how far they dropped. He tied it to work-life blend rather than balance: someone going through a divorce, a loss, or a partner’s illness is not going to perform the same way, and expecting a clean split between personal and professional life isn’t realistic.

Chaos is the part worth talking about. Jessica’s closing thought, and the reason she agreed to the conversation. She hid behind her story for a long time and worked to make her life look less chaotic than it was. She came to see the chaos as the thing that made her who she is and the leader she became. Her two closing quotes: an African proverb that smooth seas do not make skillful sailors, and one attributed to Winston Churchill, that success is not final and failure is not fatal, and it’s the courage to continue that counts.

One thing to bring back to your team

Take five minutes and write down the three experiences that most shaped how you lead.

If any of them are on your resume, keep going. Jessica’s argument is that the formative ones almost never are. They’re the coach who asked what your plan was instead of telling you. The season you lost badly and had to own it. The job that ended before you were ready. The thing you got back up from so many times you stopped counting.

For leaders looking to take this further, Nick Capman’s book The Passionate Workforce: How to Create and Maintain Maximum Employee Engagement expands on creating high-trust cultures where ideas and people can thrive.

Drawing from practical strategies, real-world examples, and proven methods, Nick provides actionable insights for leaders at every level. Whether you’re refining your leadership style, implementing engagement initiatives, or preparing your team for the future, this Amazon #1 bestseller equips you with the tools to transform your organization from the inside out.

If you haven’t picked up a copy yet, it’s an invaluable resource for any leader serious about maximizing employee engagement and creating a workplace where passion and performance are inextricably linked. Grab your copy on Amazon.

The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates.

Need expert help planning and executing compliance projects or connecting with a quality and compliance professional? Get in touch with us. If we haven’t worked together yet, watch our explainer video below or head to our company introduction page to see if we could help you execute your projects now or in the future.

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We have an important (and quite long) breakdown for the device and medtech professionals among us.

The Quality Management System Regulation took effect on February 2. The same day, FDA retired the Quality System Inspection Technique and replaced it with a risk-based inspection approach in an updated compliance program, CP 7382.850.

Three warning letters from that new regime are now public. All three came out of inspections that began within days of the effective date, two of them on February 2 itself. And all three cite ISO 13485:2016 Clause 7.1, risk management in product realization.

Before we get into them, note that FDA has addressed the QMSR transition in several letters issued after the effective date where the underlying inspections happened before it. See the letters to IsoTis OrthoBiologics, Longhorn Vaccines and Diagnostics, and Medline Industries. Those allege QSR violations and cite 21 CFR Part 820 as it applied at the time, while making clear that corrective actions proposed or implemented after February 2, 2026 must comply with the QMSR. We’re treating them as pre-QMSR here.

The first citations land hard on risk management

The biggest practical shift from the QMSR is how central your risk management documentation has become.

Investigators are instructed to identify product risks from multiple sources before and during the inspection, then to work with your risk management documentation throughout the visit to understand those risks and their controls, and to help decide what else to examine. Before they arrive, those sources include MDRs, reports of corrections and removals, complaints including trade complaints, and compliance data.

What used to be four QSIT subsystems are now six QMS areas:

Four other FDA-specific requirements are built into the inspection models as applicable: MDR, reports of corrections and removals, device tracking, and UDI. (Keep that last one in mind, because it produced a citation in one of these letters!)

Two models govern coverage here. Model 1 applies to non-baseline surveillance, compliance follow-up, for-cause, specific product risk assignment, and PMA postmarket inspections. The investigator identifies product risks and selects at least one element from each of the six areas, plus the applicable OAFRs. Model 2 applies to baseline surveillance and generally to PMA preapproval inspections, and instead of leaving selection open, FDA specifies a broader minimum set of elements to evaluate in each area.

The practical consequences are huge. Your risk documentation shapes where the investigator looks next. If it’s incomplete, that can produce a finding on its own while also pushing the investigator to triangulate risk from complaints, postmarket data, process records, and returns.

One note on sourcing: everything stated as fact below about these firms is drawn from FDA’s stated findings in the warning letters rather than independent findings by us. Warning letters are informal and advisory rather than final agency actions, and the regulatory status of the issues described in them can change through subsequent interactions between the FDA and the recipient. We’re saying that once rather than repeating ‘FDA found…’ throughout.

Linemaster: five violations, and the same problem in every response

FDA inspected Linemaster’s Woodstock, Connecticut facility from February 4 through March 6, 2026. The firm makes foot pedal accessories, including Class II foot pedal controls used with Class IV medical lasers. It responded to the 483 on March 30. FDA issued the letter on May 27.

• Rework that was never written down (8.3.4). Linemaster’s procedure required rework instructions on an MRR or form Q6-12. An assembler failed to complete a screw step after calibration, and the supervisor had every unit in the job torqued and recalibrated. None of it was documented. The FDA added a line explaining why this mattered: inadequate calibration of these pedals may result in unintended laser activation or inadequate laser power delivery.

• A risk procedure that didn’t say who, how, or when (7.1). The firm’s procedure calls for Process FMEAs on the highest processing risks, but there was none for the foot pedal accessory used with Class IV lasers. The FDA then went into the procedure itself, which never defined how risk activities are performed and documented, who conducts and approves them, when risk documentation must be updated, or how postmarket feedback, including complaints, adverse events, and recalls, gets incorporated.

  Those four gaps are among the most “portable” findings in these letters. Nothing about them is product-specific, and they’re visible from the procedure itself without first having to establish a product-specific failure.

• A corrective action request closed with a blank root cause (8.5.2). SCAR-00014, opened November 14, 2023 after six foot pedals failed calibration verification at a customer site, was never investigated. The response sent to the customer on January 26, 2024 shows a blank root cause and “NA” under corrective action. It had remained uninvestigated for more than two years by the time of the FDA’s 2026 inspection.

• A known temperature effect with nothing monitoring it (6.4.1). Request for Engineering Assistance #20130763 documented an unintended change in a sensor’s output due to temperature fluctuations, causing measurement inaccuracies over time. The only control implemented was a firmware feature. No procedures, no environmental monitoring, no data showing the devices hold calibration across temperature. The FDA cited the absence of procedures or controls to monitor temperature despite the firmware feature, because Linemaster had already identified temperature fluctuations as capable of affecting sensor output and calibration accuracy.

• Test software not validated to catch bad units (7.6). The Monitor Program software used for calibration and final testing had a validation record with no raw data, no pass/fail criteria or results, no statistical analysis or sample size rationale, and no verification that the software accurately measures output values and reliably detects nonconforming devices. The firmware validation was separately missing testing across temperature ranges, correlation between temperature and sensor output, raw data, statistics, pass/fail criteria, temperature cycling, and any calibrated-versus-uncalibrated comparison.

Koven: an undocumented intended-use change implemented by a critical supplier

FDA inspected Koven Technologies in Saint Louis from February 2 through February 6, 2026, opening the day the QMSR took effect. The firm markets the Bidop 3 Doppler and holds 25 510(k) clearances for devices designed and manufactured by a contract manufacturer.

Koven’s president sent three responses, on February 27, April 17, and May 28. FDA issued the letter on July 21. For each of the four cited violations, FDA said the adequacy of the responses could not yet be determined because corrective actions remained in progress or supporting documentation was missing.

There’s a lot here, so let’s walk through it. The same caveat applies: everything we’re stating as “fact” is what the FDA alleges in its warning letter.

An uncleared fetal indication with no record of how it got there (7.3.9).

The Bidop 3 was cleared in March 1996 under K954397 for non-fetal use. The investigator found that the operations manual lists detection of fetal heart sounds among the indications for use. Koven’s own Design Control procedure requires design changes to be identified, documented, validated where appropriate, reviewed, and approved before implementation.

The FDA listed three things the firm couldn’t produce:

1. any design change review and approval showing what hardware, software, or performance specifications were modified for fetal use, along with validation data for that application;

2. any evaluation of whether the change from non-fetal to fetal indications required a new 510(k);

3. and the date it began distributing the Bidop 3 as a fetal doppler.

Clause 7.3.9 asks you to determine a change’s significance to function, performance, usability, safety, and regulatory requirements. The regulatory piece is especially important here. The FDA found no documented evaluation of whether changing the indication from non-fetal to fetal use required a new 510(k). If that significance assessment isn’t documented, FDA has no record showing that the regulatory question was evaluated.

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Being “nice” can sometimes mean avoiding a conversation that ought to be had. Being “kind” should mean having it respectfully.

That distinction lies at the root of most issues with emotional safety in small companies, and it’s where Nichole DiLoretta started when defining these terms in the context of company operations. “Nice” avoids conflict and keeps the peace. “Kind” means understanding why someone feels the way they do and dealing with it. One of those solves problems, while the other covers them and hopes they go away.

Nick Capman sat down with Nichole to talk about what small companies lose when leaders misread emotional safety and what it costs before any performance metric moves.

Nichole is Vice President of Quality at Sterling Pharmaceutical Services, with nearly two decades in life sciences across quality and operations. She has run sites, served as the buffer between executive management and site leaders across multiple locations, and worked as a GxP compliance consultant inspecting pharma, medical device, and laboratory operations.

Before Sterling she was Chief Quality Officer at Apertus Pharmaceuticals, and she held a series of roles at DYNALABS including Senior Director, Site Director, and Vice President of Operations. Earlier in her career she was a quality consultant at Pfizer and a quality engineer at bioMérieux.

She also became a laboratory manager six months into her first job out of college, which shaped how she thinks about all of this.

Key insights from the discussion

Nice avoids the conversation. Kind has it. Nichole’s framing is that being nice usually means dodging conflict to keep the peace, which doesn’t solve anything. It papers over the problem. Kind means understanding the empathy underneath, why someone feels what they feel, and dealing with the actual root. Nick’s version: if someone asks how they look before something important and they’re wearing a tutu to an executive meeting, nice says “you’re fine” and lets them embarrass themselves. Kind says something.

Communication is the root of most of it, and everyone thinks they’re better at it than they are. Nichole returned to this repeatedly. Nobody feels safe when they can’t communicate and don’t feel understood. That’s the foundation everything else sits on.

Trust comes before conflict, and conflict isn’t arguing. Nick folded in Patrick Lencioni’s model: leadership teams have to trust each other before they can have productive conflict. Conflict here means being able to hold and voice a different opinion. People without emotional safety don’t raise important information, because they’re calculating the anticipated negative consequences.

Believe people about themselves. This was Nichole’s sharpest practical instruction. If someone tells you they aren’t trained, believe them. If someone says they don’t understand something, believe them. If someone says they aren’t comfortable doing a task, believe them. Why would they raise it otherwise? Yes, a small percentage of any workforce is angling to avoid work, but building your leadership approach around that minority costs you the majority.

Dismissiveness is the lighter shade of disbelief, and it does nearly as much damage. Nick added this. You might believe someone was trained, so when they say they still don’t feel comfortable, you say “you’ll be fine.” You listened, but you didn’t hear them. Do that repeatedly and the employee concludes that speaking up is banging their head against a wall.

Being good at the work doesn’t make someone good at leading. Nichole applies the bench scientist comparison to small-company leadership generally. Someone who was expert at a specific technical thing gets promoted and is suddenly assumed to have the nuance of good leadership and emotional safety. Those are different skill sets, and nobody handed them the second one.

No control without measurement. Nick’s contribution, and one that lands with a life sciences audience. If you aren’t measuring the mindset of your employees, you don’t know it. You might have a good instinct and you might even be right, but you don’t know until you validate it.

Hallway conversations are not data. Small companies run on informal check-ins, and Nichole flagged the problem with them. When the person asking “do you like it here?” has complete control over your job and job functions, you’re going to say you’re fine. The leader hears what they wanted to hear, doesn’t dig, gets no examples and nothing measurable, and walks away with a false assumption that everyone loves it.

Nobody quitting doesn’t mean everything is fine. Job searches take a long time, and quiet quitting doesn’t get announced. Absence of a mass exodus is not evidence of health. Neither is the absence of complaints, because if emotional safety isn’t there, people aren’t bringing you complaints anyway.

Even in a safe company, there’s a veil between levels of power. Nick made a point worth sitting with. You can build the most emotionally safe organization possible and there is still a barrier between you and anyone whose job you control. When someone weighs radical candor against their family’s financial security, candor doesn’t always win. Leaders should understand that veil exists rather than assume they’ve eliminated it.

By the time someone comes to you, the frustration has been building. Nick’s advice is to probe rather than wait, and he framed it in terms his audience knows: this is root cause analysis applied to people rather than deviations. On the spectrum from passion to resentment, a person who finally raises something has usually drifted well toward resentment, which means the odds of losing them are already higher than you’d want. As he put it, tell me if you don’t like the coffee or the color of my shirt, because problems are much easier to handle when they’re small.

The first sign is that people go quiet. Nichole named this as the number one indicator, and she’s watched it happen in environments she was in herself. You see the passion drain. People stop offering ideas because they’ve been shut down, mocked, or had it make the rounds as inappropriate. They stop taking the reins on projects, not because the work won’t be appreciated but because one small mistake out of a hundred good things will be the one that gets highlighted. And when someone’s ideas get brought up as silly after they leave, everyone still there learns not to be that person.

Watch for the quiet ones who start talking back. A less obvious signal Nichole flagged. People who rarely spoke suddenly making comments, with resentment audible in them. Also worth noticing: consistent Monday call-ins.

Hive mentality means the gap has opened. When people who never collaborated before start clustering together, that’s a group finding safety with peers because they aren’t finding it above them. Nichole described it as a widening gap between leadership and everyone else, and it takes real attentiveness to catch, since you can’t see it from a tower looking down.

Your best low-maintenance performer is carrying hidden workload nobody assigned them. This was the most useful stretch of the conversation. The high performer who doesn’t cause ruckus becomes the neutral ground people go to. Am I crazy for thinking this? What’s your read on that? They absorb it, they don’t complain, and they hide the struggle because they’re known for not creating tension. Then they take it home. And because they’re “fine,” nobody checks on them.

That burden has to be addressed, not admired. Nick asked whether it genuinely needs fixing. Nichole’s answer: yes, because the cup always runs over. She compared it to emotional burnout in social work and veterinary medicine. The person absorbing it usually doesn’t have the authority to change it. The leader does. That makes it the leader’s job, and if a leader can’t recognize it and step in, Nichole isn’t sure they should be in leadership. Even acknowledging it goes a long way.

No HR department is not an excuse. For an eight to ten person company with no HR function, Nichole is direct: it’s the owner’s job. If you’re not good at it, that requires the humility to say so, and then go get the training. Bring in an outside consultant monthly or weekly, use fractional positions, run real leadership training. It isn’t especially expensive. Burying your head costs more, in good people and in the ideas you never hear.

Not every complaint is valid, and here the advice flips. Nichole named this as the deliberate opposite of everything else she said. When someone makes a factual claim about themselves, believe them. When something is emotionally charged and rests on their perspective of a situation, don’t believe the first thing you hear. There are probably ten sides to every story, not two, and not even the classic three. It takes an investigative posture, probing others close to the situation and forming a view rather than accepting the first account. She also noted the layoff example: employees who ask why they weren’t told often have a fair emotional point and an unworkable request at the same time.

Saying no is fine. Not having the conversation is not. Even when a complaint isn’t actionable, sit down and explain why. Small companies expect people to work as a group and then avoid group conversations. Have it, and it may not come up again.

The costs are real and mostly hidden. Turnover is the visible one, and every HR and finance team knows replacement costs more than retention. The larger loss is innovation. People who don’t feel empowered don’t offer ideas, and Nichole strongly believes that diversity of background is where the best innovation comes from. If everyone came from the same place, everyone does it the way it’s always been done. Nick’s addition: experience is what helps you avoid pitfalls, so silence costs you the pitfalls you would have missed.

Three changes leaders can make quickly. Start with communication, including the humility to say the approach hasn’t been right and to ask people for their ideas on fixing it. Nichole guarantees staff go home thinking leadership actually wants to listen. Second, invest in training, less because it teaches something entirely new than because it brings what you already half-know back to the front of your mind and makes you practice it. Third, ask for anonymous feedback with pointed questions rather than “How do you feel?” Ask whether the open-door policy is real. Ask whether people feel supported in their ideas. Then listen to the answers instead of guessing who wrote them.

You don’t have to fix all twenty problems. If you survey twenty people, Nichole’s expectation is that most of the answers are rooted in a few similar places. Fix one thing at a time. Nick’s version, borrowed from What About Bob?, is baby steps, with the reminder that this is a journey that never ends and that leaders already understand what compounding 1% improvements does.

One thing to bring back to your team

Think about who in your organization everyone goes to.

Not the person on the org chart. The one people actually walk over to when they want a sanity check, when they’re frustrated, when they need to know whether they’re crazy for thinking something. That person is doing work nobody assigned them, they probably aren’t reporting it, and they’re likely the one you check on least because they seem fine.

For leaders looking to take this further, Nick Capman’s book The Passionate Workforce: How to Create and Maintain Maximum Employee Engagement expands on creating high-trust cultures where ideas and people can thrive.

Drawing from practical strategies, real-world examples, and proven methods, Nick provides actionable insights for leaders at every level. Whether you’re refining your leadership style, implementing engagement initiatives, or preparing your team for the future, this Amazon #1 bestseller equips you with the tools to transform your organization from the inside out.

If you haven’t picked up a copy yet, it’s an invaluable resource for any leader serious about maximizing employee engagement and creating a workplace where passion and performance are inextricably linked. Grab your copy on Amazon.

The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates.

Need expert help planning and executing compliance projects or connecting with a quality and compliance professional? Get in touch with us. If we haven’t worked together yet, watch our explainer video below or head to our company introduction page to see if we could help you execute your projects now or in the future.

This guidance breakdown is available in full to paid subscribers. Only paid subscribers get regular full access to our guidance breakdowns and other analyses. If you’re not already a paid subscriber, you can upgrade here.

We’re catching up on some final guidances the FDA has been issuing recently. We realize any given guidance may be relevant to only a small subset of our audience, but the one we’re looking at today has broad relevance for the OTC drug professionals among us who interact with the FDA.

Last month, CDER’s Office of Nonprescription Drugs issued final guidance on formal meetings between FDA and sponsors or requestors of OTC monograph drugs. It finalized a draft of the same title from February 2022 and is classified as “procedural.”

At a high level, the guidance does three statutory jobs at once:

If you work in the OTC monograph drug space, this is basically the operating manual for getting FDA advice. Two things make it different from the meeting process you may know from the NDA world. First, it runs on its own meeting taxonomy with its own clocks. Second, because the monograph order process is public, what you submit in connection with a meeting can end up public, too.

Excuse the length in this one — there’s a lot here!

Who and what this covers

The guidance applies to formal meetings requested by sponsors or requestors of nonprescription drugs without approved NDAs governed by section 505G, or by organizations nominated to represent their interests in a proceeding.

It calls all of them “meeting requesters.” (Fun fact: Section 505G was introduced by the CARES Act in March 2020.)

It also covers meetings for advice on clinical investigations under an IND, where the purpose of the IND is to support a determination of whether a nonprescription drug is generally recognized as safe and effective under certain conditions. It does not apply to nonprescription products being developed for submission in NDAs or ANDAs under section 505.

The three meeting types

This is the core taxonomy. Let’s run through each!

Four formats, and the FDA gets to pick

In addition to the three meeting types, there are also four formats.

An important detail we caught on the hybrid format is that if your core personnel are not planning to attend in person, the guidance says you should request a virtual face-to-face meeting instead. If core personnel are suddenly unable to travel due to illness or unexpected travel issues, they can join virtually.

You can request a specific type and format, and for any meeting type, you may request a written-only response. But the FDA reviews the request and determines whether to grant it, the appropriate type, and the appropriate format.

So in essence, the format is FDA’s call, generally informed by the complexity of your questions.

The clocks and timing around meetings

Three timing rules matter here: The FDA’s OMUFA II response-time goal, its meeting-scheduling or WRO goal, and the deadline for submitting the meeting package.

Note that the written response timelines match the scheduling timelines for the same meeting type.

We noticed a scheduling wrinkle here that you’ll want to be aware of. The FDA schedules for a date when all expected FDA staff are available, consistent with the type granted. But if the date you requested falls later than the standard scheduling window, FDA should schedule within 14 calendar days of your requested date.

Now hold the scheduling window and the package deadline side by side.

• For a Type Y meeting scheduled at the outer edge of its window, day 70, a package due 50 days before the meeting lands around day 20 after your request.

• For Type Z at day 75, a package due 47 days out lands around day 28.

• And if FDA schedules your meeting earlier than the outer bound, your package deadline moves up with it. An earlier meeting date actually shortens your preparation runway.

Type X has no runway at all! The package is due at the time of the request, so it has to be finished before you ask.

Getting the request right and the OMUFA split

Submitting electronically is a statutory requirement under 505G(j). Beyond that, the guidance draws a distinction that’s kind of easy to miss.

It says all requesters should submit through the CDER NextGen Portal, but to qualify for OMUFA II performance goals they must. Same portal, different “force.”

The same split runs through content. A nine-item list covers what the request should include:

Then it gives a separate 8-item list of what the request must include to qualify for OMUFA performance goals:

To our eyes, you should treat that second list as an actual filing checklist. It’s going to be what stands between you and the performance goal timelines.

On requested FDA attendees, the guidance is candid about the tradeoff. Asking for FDA staff who are not otherwise essential may affect the ability to hold the meeting within the time frame for that meeting type. If you request nonessential attendees, justify them and state whether a later date would be acceptable.

Ten questions in one hour

The meeting request should generally have no more than ten questions, listed consecutively regardless of discipline. The FDA asks you not to use subquestions because they get counted toward the total anyway.

Three parts to your first question means numbering them 1, 2, and 3, not 1a, 1b, and 1c. Three clinical and three nonclinical questions can sit under subheadings but should run Clinical 1 through 3 and Nonclinical 4 through 6.

The limit in questions is because there’s a limit on time: meetings are generally one hour, and you are asked to limit questions to what can reasonably be answered in that time.

What goes in your package

The package must be submitted electronically, and the guidance says you should send it through the CDER NextGen Portal.

Content should be organized according to your proposed agenda, sequentially paginated, with a table of contents, electronic linkage, and appropriate indices, appendices, and cross-references so reviewers can navigate it during the meeting as well as before.

The package generally should include fifteen items, starting with the same first six from the request, then:

• The USP active ingredient monograph if applicable

• The proposed OMOR tier, dosage form and route and dosing regimen

• A full attendee list with titles and affiliations including consultants and interpreters

• A background section

• A brief purpose statement

• The proposed agenda with times

• The final questions numbered identically to the request

• Data to support discussion organized by discipline and question

The FDA also generally expects your non-FDA attendees to be limited to those listed in the package and expects advance notice of changes.

Preliminary responses and the gotcha

For Type Y and Type Z meetings, the FDA sends preliminary responses to your questions no later than five calendar days before the meeting date. The FDA says it generally does not send preliminary responses for Type X meetings.

You then have a short window! Within three calendar days of receiving the preliminary responses, you should tell the FDA whether the meeting is still needed. If it is, send a revised agenda marking which questions you consider resolved and which you still want to discuss.

Here’s the “gotcha” we’re seeing here:

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These RA/QA news rolls are available in full only to paid subscribers. Upgrade here. If you haven’t already taken our reader survey, it should only take 1 minute here.

This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.

If you haven’t upgraded to a paid subscription yet, you can do so here. Also, make sure to follow us on LinkedIn and catch the latest episodes of our podcast, The Life Science Rundown.

Here are some key items from the past couple of weeks.

💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.

Special Announcement!

We're excited to announce a very special guest coming on the Life Science Rundown podcast in September: Robert M. Califf, MD, MACC!

Dr. Califf currently serves as an Instructor in the Department of Medicine and a Member of the Duke Clinical Research Institute at Duke University, and is an Adjunct Professor of Medicine in the Division of Cardiology. He previously served as FDA Commissioner and Deputy Commissioner for Medical Products and Tobacco. Before his FDA roles, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke, director of the Duke Translational Medicine Institute, and founding director of the Duke Clinical Research Institute.

He is also a Member of the National Academy of Medicine, has served on multiple FDA advisory panels and NIH advisory committees, and has led major initiatives to improve methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI).

More details to come. If you aren't already, make sure you're subscribed wherever you listen to podcasts so you don't miss our conversation! We’ll of course post it here on the Insider Newsletter, too.

Alright, back to our regular newsroll items:

FDA Leadership and Administration

• More detail emerges on the “Simple Reform” reorganization: The reorganization notice the FDA published in late July would restructure key parts of the agency, and HHS has confirmed it is intended for implementation on October 1, the start of federal fiscal 2027. Under the plan, the scope of the Office of Operations expands significantly, as does the Office of Public Affairs. The notice establishes a new Office of Mission Information and Technology Services, an Office of National Health Security, and an Office of Health Advancement.

• Officials push back on the inspectorate reading: Associate Commissioner for Inspections and Investigations Elizabeth Miller and Acting Chief of Staff Lowell Zeta published an FDA Voices blog addressing concerns that the reorganization would undo the 2017 “Program Alignment” restructuring of inspections staff. The specific worry among stakeholders was that investigators would move into generalist roles rather than specializing by product type and subject matter.

• Ibrahim named permanent CDER deputy director: Veteran regulator Sarah Ibrahim was named permanent deputy center director for regulatory programs at CDER after eight months in the role on an acting basis. She joined CDER in 2014 and worked in the Office of Generic Drugs. The agency has still not announced who will lead CDER permanently; Mike Davis has held the role on an acting basis since May.

• Mullin retires from CDER: Theresa Mullin, who led CDER’s patient-focused drug development initiative and international work as associate director for strategic initiatives, has retired from the agency. Mullin joined CDER in 2007 after serving in the Office of the Commissioner as assistant commissioner for planning.

• CBER leadership applications closed: The job postings for CBER Deputy Center Director and Office of Therapeutic Products super office director closed August 5. The White House and HHS are still expected to announce their plans for the agency’s top ranks as a suite of senior leadership hires.

• FDA consolidates its social media presence: The agency is deactivating several legacy accounts on X and will post from @FDA, @FDADrugs, and @FDADevices instead of its various other handles. More specific accounts, including @FDASpox, @FDAOncology, @FDACBER, @FDAWomen, @FDACDERDirector, and @FDAMedia, will be deactivated September 12.

• HHS publishes its semiannual regulatory agenda: HHS released the agenda listing regulatory activities the department expects to undertake in the foreseeable future, a component of the Unified Agenda published in July. It indicates the FDA is expected to issue proposed rules on direct-to-consumer advertising and nonclinical testing, a final rule on Patient Medication Information, and a long-term action on prescription drug marketing. The HHS agenda contains fewer entries than the Unified Agenda and introduces no new FDA topics.

FDA General

• PDUFA VIII commitment letter published: The FDA released its draft commitment letter for the eighth iteration of the prescription drug user fee program, covering fiscal years 2028 through 2032. The letter covers review performance goals, a new pivotal protocol prioritization commitment, a CMC facility lifecycle program with new pre-submission and post-inspection meeting types, enhancements to formal meetings including multi-divisional meetings, and continued work on cell and gene therapy. It also proposes removing some PDUFA VII elements, including the STAR pilot and the CMC Development and Readiness Pilot. Comments close October 16, and a public meeting is set for September 16.

• GDUFA IV commitment letter proposes onshoring incentives: The FDA released the draft commitment letter for the fourth reauthorization of the Generic Drug User Fee Amendments, which expires in September 2027. Proposals include updates to ANDA review timelines and communications, a new meeting structure, and a provision letting certain existing U.S. facilities request surveillance inspections ahead of an ANDA, prior approval supplement, or drug master file submission. The agency also recommends statutory changes raising the foreign facility fee differential from $15,000 to $25,000. A public meeting is set for September 17.

• Formal meetings guidance finalized: 💊 The FDA finalized its recommendations on formal meetings between the agency and prescription drug product sponsors, replacing a 2023 draft. The 24-page document describes meeting types, formats, and requests, along with procedures and content for meeting packages. It applies to sponsors of drugs or biologics regulated by CDER or CBER, and preserves the structure and much of the content of the draft with modest changes.

• New draft guidance on container closure systems for drugs and biologics: 💊 Two weeks after issuing guidance on container closure systems for biosimilars, the FDA released a broader draft guidance on CCS for drugs and biologics. When finalized, the document would supersede the agency’s CCS-as-packaging guidance from 1999 and 2002. The draft signals a larger revamp, stating that the FDA intends to supplement it with additional topic-specific guidances.

• Biosimilar presentations draft guidance issued: 💊 The FDA issued a draft guidance on container closure systems and device constituent parts for biosimilar and interchangeable biological products, known as the presentation of the medicine. The recommendations expand on the 2021 biosimilar Q&A guidance, with emphasis on design differences between originator and biosimilar presentations, and focus primarily on assessing the user interface for combination products through a three-step comparative analysis.

• Transdermal and topical generic guidances released: 💊 The FDA issued a final guidance on assessing adhesion with transdermal and topical delivery systems for ANDAs and a third draft of its guidance on assessing irritation and sensitization potential. The adhesion guidance follows three prior drafts, the most recent from 2023. The irritation and sensitization revision updates recommendations on when sensitization studies are not needed and when a combined study is appropriate. A workshop on bioequivalence for topical and transdermal generics is set for September.

• Human factors guidance takes effect, and the 2016 guidance is updated: 💉 The FDA’s new final guidance on the content of human factors information in device submissions went into effect over the weekend of August 1, as the older eSTAR and PreSTAR templates were retired. The agency also issued the anticipated conforming updates to the 2016 human factors guidance, removing Appendix A, a sample outline of a human factors report, which is now covered in the new content guidance. The 2016 document lost about four pages.

• First mRNA flu vaccine approved: 💊 The FDA approved Moderna’s seasonal influenza vaccine mFlusiva in adults 50 and older, six months after former CBER Director Vinay Prasad controversially refused to review the product. The agency granted full approval in adults 50 to 64 and accelerated approval in the 65-and-older cohort, reflecting Moderna’s amended application, with a required postmarketing study to confirm benefit in older adults. The Phase 3 trial enrolled 40,805 adults across 11 countries and showed 26.6% relative vaccine efficacy against a standard-dose comparator. The June advisory committee had voted unanimously in favor in both age groups.

• Quantitative Medicine Innovation Network takes shape: 💊 The FDA published a request for information asking what the new Quantitative Medicine Innovation Network should do, tied to CDER’s Quantitative Medicine Center of Excellence. A September 1 meeting with the Duke-Margolis Institute will inform the effort, and the speaker list includes acting CDER Director Mike Davis, QMCoE Director Rajanikanth Madabushi, Office of Clinical Policy Director Issam Zineh, regulators from the Swedish Medical Products Agency and the European Medicines Agency, and FDA veteran Janet Woodcock.

• Drug repurposing meeting held: 💊 The FDA presented an early look at its analysis of drug repurposing feedback at a hybrid public meeting hosted by the Reagan-Udall Foundation on August 5. The docket, which closed in July, addressed disease areas with significant unmet need where sufficient evidence may already exist to support a new use, cases with promising preliminary data, and general barriers and opportunities.

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It’s officially annual audit planning season for 2027. For the next few weeks and months, we take teams’ audit schedules and formally assign auditors to them.

With many companies kicking off their first audits in January, planning for those and the rest of the year’s audits should be done over the next 8 weeks, with everything ideally ready by October 1.

If that sounds early, run the math backward to see why we push for October:

Now consider where those steps land on a calendar. Agendas are often drafted and approved in November and December, when the people who have to approve them are out and many sites are closed. In our experience as the resourcing partner for teams needing to get great auditors into their sites throughout the year, January (and Q1) is hard precisely because everything that has to happen before it happens during the holidays.

Practically speaking, you can’t solve that with urgency in December. You solve it with a list in October, well before crunch time.

In this guide, we’re peeling back the curtain on what goes into effective annual audit planning, how resourcing actually works, and how to plan for next year now.

We’ve also built an Excel workbook you can download and use yourself. Download the file here:

Download the Excel workbook

It’s super easy to use! Just fill in each row in the “Audit schedule” sheet with details about your 2027 audits — one row per audit. Many of the columns have dropdowns that pull from the “Lists” tab. You can update that information to customize it however you want. I

If you need to resource those audits, just head to our contact form and let us know you’re interested. We’ll reach out, and you can send your planning sheet over so we can get started.

What we ask for, and like to have by October

Let’s talk about what goes into audit resourcing.

Below is what we ask our own clients to send us, ideally in that first week of October, to resource their next audit cycles. It’s necessary information to gather no matter how you run your program.

That usually comes together on one sheet, ideally one line per audit, with enough on each line that we can quote out the program, assign auditors, and start booking dates. (Download our Excel workbook and fill it out!)

That’s really the whole ask, but we realize there’s work involved to get there!

For most Quality teams, the real work sits upstream — for example, deciding which of your suppliers actually have to be audited in the next 12 months. That’s a risk-based judgment about frequency, supplier criticality, performance history, change activity, and whatever else your SOP commits you to. Sometimes that requires cross-functional input and can take some time.

The second workstream, if you’re coordinating dates yourself, is what we call calendar reality. The calendar presents all kinds of hurdles, some less obvious than others, especially if you’re planning internationally.

• European sites shut down for stretches of August.

• Chinese New Year moves every year.

• Some sites won’t host an auditor during a campaign or a turnaround. You find all of this out one email at a time!

The key point is that both of these things should be August and September problems to solve. December is just too late to expect the same kind of result.

What follows is the sequence we’d run if we were building the list ourselves. Work through it, and you’ll have a schedule we can price and resource, and a documented record of how you decided what to audit. Do your future self a favor!

Building the audit planning list: a working sequence

Let’s run through this one step at a time.

1. Pull your “audit universe” into one sheet

Start wider than you’ll finish. Pull from your approved supplier list, your quality agreement register, your CMO and CRO contracts, your contract lab list, your prior audit schedule and reports, and your internal site list. If you run clinical programs, add TMF and eClinical vendors.

You might find that these sources sometimes “disagree” with each other. Some examples we’ve seen include:

• Suppliers on the ASL with no quality agreement.

• Quality agreements for suppliers nobody has audited in five years.

• Vendors added in mid-2026 who never made it onto a schedule.

Finding those now is worth the afternoon it costs, because each one is a purchasing control or supplier evaluation observation waiting to happen.

2. Apply the intervals, then apply any “overrides”

Some companies have an SOP or a documented program that defines audit frequency by risk tier. Apply that first: anything whose interval expires in 2027 obviously goes on the audit list.

Then apply the “overrides,” which is where the judgment actually lives. A supplier might belong on the 2027 audit list regardless of where its interval sits if any of these happened since the last audit:

• Quality events traceable to them: deviations, OOS results, complaints, rejected lots

• A change in ownership, site, process, or a material’s manufacturing location

• New material, expanded scope, or first commercial supply

• Regulatory action against them, or an inspection that produced significant findings

• Open CAPAs from the last audit that nobody verified as closed

• No audit on record at all

Jot down the reason next to each line as you go. That column is the record of your risk-based decision. (It’s also what an investigator asks about when they want to know why the supplier behind your last three deviations wasn’t on the schedule!)

3. Classify each audit before you try to schedule it

Every line needs a type and a format.

• Type is the GxP: GMP, GCP, GLP, GCLP, CSV, pharmacovigilance, quality system.

• Format is on-site, remote, or hybrid, plus expected duration in days, plus whether it’s a first-time qualification audit or routine surveillance.

Duration is important too and is sometimes overlooked in initial planning. A two-day audit and a four-day audit are different resourcing projects, different budget lines, and different conversations with the site. Make sure you note the length of each audit.

4. Place the constraints first, then fill in around them

One mistake we sometimes see teams make is spreading audits evenly across the year and then discovering the constraints after the fact that force changes.

We suggest doing it the other way:

1. Mark every window you can’t move. Site shutdowns, which means most of August across much of Europe, Chinese New Year, Golden Week, and regional holidays wherever your suppliers sit. Campaign and turnaround windows. Year-end inventory freezes. Any site you already know is expecting a regulatory inspection.

2. Then add your own fixed points: submissions that could trigger a PAI, product launches, your internal audit cycle, and the weeks your own quality team is unavailable to host or travel.

3. Then place the rest on the calendar, with two rules in mind. Keep Q1 under about a third of the program, if possible, because January and February are the busiest months in the industry, and a slip there might have nowhere to go. And keep December nearly empty, because a December audit that slips doesn’t move to January. It falls out of the year, and a missed interval you can’t explain is a finding.

Here’s the recurring shape of the year in case you want to avoid problem windows based on your site locations:

5. Get the right contacts, and read the quality agreement while you're there

You need the person who can approve an audit date, not the commercial contact or someone without actual authority. Name, title, direct phone, email, time zone. Note the working language and whether you’ll need an interpreter, because that can change who can run the audit.

While you’re in the file, confirm the quality agreement is current and says what you think it says about audit rights, notice periods, and how many audit days you get per year. Notice periods often drive scheduling. Some agreements require 60 or 90 days, which quietly rules out Q1 for anything you haven’t already asked for.

6. Mark every line as retain, rotate, or open

If you have audits from this year, pull the auditor names from those reports and add them to the sheet. Then decide line by line rather than as a policy.

Decide whether to retain the same person if available, rotate in someone else, or leave it open if you don’t have a preference and would rather we optimize for availability, location, and cost.

Then send the list over as complete as you can get it. A schedule with 30 lines and 6 unknowns is workable in October. A perfect schedule two days before Christmas is not!

Decide who you want back before someone else books them!

Some of the teams we manage audits for get attached to specific auditors for good reasons. An auditor returning to a site already knows the layout, the systems, the history, and what was still open at the end of last year’s report.

There’s no universal right answer here whether you want to keep the same auditors or rotate in new ones — every situation and perspective is different. Just decide this sooner rather than later, especially if you want to retain people.

What we run, and how the year works

Most annual programs are built from GMP, GLP, GCP, GCLP, and CSV audits, plus quality system audits, supplier and vendor audits, and gap assessments.

Pharmacovigilance audits are appearing in more programs than before. Beyond the standard set, we run data integrity, clinical site, MDSAP, ISO, QMSR, and REMS audits, along with mock FDA inspections, mock PAIs, mock BIMO inspections, and facility readiness reviews for teams that want a dry run before the agency arrives.

One proposal can cover the whole program if you want it to. Tell us in October that you have 30 audits and you get a single 2027 audit support proposal covering all 30. Add to it during the year if you need to, or drop audits that fall away. Adjust as your risk assessment moves. You aren’t papering a new agreement every time the plan changes.

How much of the running we do is up to you. In a fully managed arrangement, we contact the sites, negotiate and confirm dates, build and circulate agendas, manage CV review and approval, run the audits, deliver the reports, and keep the master schedule current.

In a more traditional audit vendor model, you own the site relationships, and we work through you: we tell you an auditor is available, say on January 14, you check with the site, we lock it in, and get the auditor in there on that date.

Either way, you get a named account manager and project manager rather than a shared inbox. Our auditors are former FDA investigators and industry professionals, and every engagement carries our Total Quality Guarantee.

Get your 2027 planning cycle started

If you already work with us for audits, contact your project manager directly. If you ran audits with us in 2026, we can hand your own data back to you: the audits we supported, when they ran, and the auditors we assigned, so you can mark up what stays and what changes for next year.

If you haven’t worked with us before, get in touch and tell us roughly what you’re planning. You don’t need a finished schedule to start the conversation. A rough audit count, the GxP mix, and the geographies are enough for us to get started. We respond within one business day.

Everything about January gets decided in October. Start the list!

Get in touch with us

Who is The FDA Group?

The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on Quality Assurance, Regulatory Affairs, and Clinical Operations.

With thousands of resources worldwide, hundreds of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee. Learn more and schedule a call with us to see if we’re a fit to help you access specialized professionals and execute your projects on time and on budget.

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Some breaking news today: President Trump announced on Truth Social this morning that he will nominate Heidi Overton as the next FDA commissioner. The nomination is subject to Senate confirmation.

The role has been vacant since Marty Makary resigned in May. Kyle Diamantas has served as acting commissioner since then, and several other senior FDA positions also remain without permanent leadership.

A senior administration official indicated more appointments should follow.

Who Heidi Overton is

Overton is deputy director of the White House Domestic Policy Council, where she’s led health policy work since the start of the term. Before joining the administration, she was chief policy officer and vice chair of the Center for a Healthy America at the America First Policy Institute.

Her clinical and research credentials are substantial. She earned her medical degree from the University of New Mexico School of Medicine and a PhD in clinical investigation from the Johns Hopkins Bloomberg School of Public Health, where she also completed a general surgery residency. She’s board-certified in public health and general preventive medicine, and she served as a White House Fellow from 2019 to 2021.

What she does not seem to have is a record of running a large organization, which is the point we’d expect most likely to surface in hearings.

A few things that stand out to us

From what we know so far:

• She’s reportedly not the first choice. Reporting from NBC News and CNN indicates the White House ran a months-long search and was still interviewing candidates as recently as Tuesday. Former Representative Brad Wenstrup declined the job. So did Diamantas, the acting commissioner, citing young children and other personal reasons.

• The policy background might cut both ways. Overton’s time on the Domestic Policy Council should help with stakeholder management. She likely knows how the White House thinks and how to work the relationships that surround the agency. But some might see that same background also making her among the most politically oriented commissioner nominees in the agency’s history. Most prior nominees had extensive medical and organizational leadership records. Overton’s path seems to have run through policy rather than through running large institutions.

• Expect questions about leadership experience. Makary faced them, and Overton likely will too, along with questions about whether the agency would make decisions on political rather than scientific grounds. Those are the lines of questioning worth watching in confirmation hearings.

• Continuity is the reasonable assumption for now. Nothing in her record we can see suggests a sharp break from Makary’s policy direction, and the choice of a politically connected insider signals the White House wants someone who can balance stakeholder demands rather than undertake some big reset of the agenda.

• The device industry's response seems positive. AdvaMed came out in support quickly, with Whitaker emphasizing the priority of keeping “transparency, consistency, and predictability” as hallmarks of CDRH review. That framing tells you what the medtech sector might be watching for!

Our initial read

Changes in commissioners usually don’t affect the FDA's statutory and regulatory floor. What can move is the pace of its work, where it puts its attention and resources, and how aggressively it uses its tools and authority.

Given that Overton hasn’t made many public statements to date that give us clear clues about what she would do as commissioner, we’re left to project based on her background and the initiatives the FDA already has underway.

A few of our light projections as of now:

An open question around execution

Unless we see quite a bit of change at the organizational level, Overton would inherit an agency with several senior roles vacant or filled in an acting capacity. Her ability to stabilize that leadership bench and convert policy direction into actual agency operations may matter more than any single initiative she announces, and it’s what we’d be watching for most.

That’s also the part most likely to directly affect industry teams. Center directors and career reviewers set the pace of your submissions and other interfacing activities. The commissioner’s office sets the “weather.” We’ll be watching which appointments follow this nomination as things move forward, as that will be a much stronger indication than anything we can surmise now.

What this means for regulated companies

Practically, not much changes tomorrow. Confirmation takes time of course, and the agency continues operating under interim leadership.

What’s maybe worth tracking now is whether the priorities set over the past year hold going forward. The FDA has spent much of that time managing itself amid workforce reductions (and, recently, on the food side, outbreak response) while advancing new guidance on AI, submissions, and inspections.

A commissioner with strong White House ties may have more success protecting agency resources than one without them.

We’ll follow this as the nomination moves forward. In the meantime, here are some non-paywalled reports on the nomination that bring more insight into the nomination:

• Trump taps White House aide Overton as next FDA commissioner / Fierce Biotech

• Trump taps Heidi Overton as FDA commissioner / Axios

• Trump expected to pick Dr. Heidi Overton to lead FDA / CNN

• Trump nominates Heidi Overton to lead the FDA / NBC News

• Trump nominates policy aide Dr. Heidi Overton as next FDA commissioner / CBS News

Who is The FDA Group?

The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on Quality Assurance, Regulatory Affairs, and Clinical Operations.

With thousands of resources worldwide, hundreds of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee. Learn more and schedule a call with us to see if we’re a fit to help you access specialized professionals and execute your projects on time and on budget.

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There’s a version of quality leadership that starts every decision with “what will the auditor think?” Julio Salwen would like that version to end!

His argument is that when you build a quality system to please an auditor, compliance becomes the objective and safety becomes incidental. Flip it! Build a strong quality system aimed at controlling real risk, and compliance follows naturally. You do the compliance check after, not upfront.

Nick Capman sat down with Julio, SVP and Chief Quality Officer at MiniMed, to talk through what that looks like in practice when you’re standing up global quality across a newly separated company while AI reshapes the work underneath you.

Julio is an engineer by training with more than 35 years of experience across pharma, devices, and diagnostics, most of it in manufacturing and quality management, with regulatory compliance experience both in and outside the US. He’s held quality leadership roles across Puerto Rico, Europe, and the United States, including Global Head of Quality for Abbott Molecular, Divisional VP of Quality for Abbott Point of Care, and VP of Quality for Medtronic’s Diabetes Operating Unit before it became MiniMed.

He also builds his own AI agents, which makes his caution about them more credible than most you might ask!

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Julio’s key insights and practical takeaways

If you’re short on time, here are the most important lessons from the discussion.

“Regulatory confidence” means decisions you can explain (not paper you can produce). Julio defines it as controlled, transparent patient innovation. Confidence comes from risk being understood and decisions being explainable, not just documented. Five years ago the emphasis sat on documentation, validation, and procedure, a more canned approach. Today it’s more fluid, which raises the demand for governance, integrity, accountability, and monitoring. He put weight on that last one: things change every day, so monitoring isn’t optional.

Stop asking what the auditor will think. This is the mindset shift he pushes hardest. Leaders should start with what risk they’re actually trying to control, then let compliance follow. He’s a fan of the QMSR precisely because he argues it enables innovation through more effective risk management. Compliance is a side benefit of a strong quality system, not the main objective. Nick’s analogy: it’s the difference between asking how to pass the test and actually learning the material. Learn it and you’ll pass.

Turning people loose on AI without definition is the biggest unintentional risk. Telling your organization to “go use AI,” without controls or a clear intended use is how leaders take on regulatory risk without realizing it. As Julio put it, you can’t ChatGPT compliance. He uses AI tools as research assistants and is explicit that he keeps the decision-making in his own brain. Without a leader setting that tone, people follow the tools blindly. He also referenced the (now infamous) warning letter where a company’s justification amounted to “this is what the AI tool told me.” That doesn’t work, and if it did, anyone could form a company, buy a few tools, and hold nobody accountable.

Introduce AI where the risk is genuinely low, then build confidence. Nothing is zero risk, so the goal is controlled, proportionate risk. Julio shares his own example where he built an agent to monitor the warning letters the FDA posts every Tuesday. When he tested it, it missed two, so he trained it. That’s a low-risk use (general knowledge, no decision being made) so he could use it immediately. Research and document drafting are good entry points. Decisions stay with qualified professionals, and he stressed the word qualified. Being a quality professional doesn’t make someone a qualified quality AI professional, because a quality professional might assume a validated tool works the way validated tools traditionally work.

Senior leaders make organizations risk-averse, one overreaction at a time. Risk aversion is the default failure mode at the top, and Julio makes clear that his people can take risks, which means things will sometimes go wrong! When something does, and it isn’t a high risk, the response should be: understood, learn from it, move on. If leaders turn those events into a big deal, that’s the problem. This needs to be explicit, and that it’s a behavior rather than a policy. Patient risk is off the table. Other risks are part of the job.

Match your controls and your reaction to the actual severity. Nick offered a useful image from a talk on risk: two pits, one shallow and wide, easy to fall into but survivable, and one narrow and deep, unlikely but severe. The controls should be commensurate with the risk, and the response when something goes wrong should be as well. Julio’s phrase for the minor version is a slap on the wrist. It only takes one slap-on-the-wrist event treated as a catastrophe to make an entire organization risk-averse.

AI can’t yet tell the shallow pit from the deep one, and that’s where humans matter. Julio’s view is that AI will largely treat both as equal, and the human has to say no — these actually aren’t the same. He agrees AI will get there, particularly as teams train tools on their own risk tolerance, which will differ from organization to organization. Today he’d use it as a reference and wouldn’t make a decision solely on it, gaining confidence over time.

Hybrid governance requires dropping the control tower. Global quality tends toward central control of everything, and Julio wants standards, accountability, and escalation mechanisms instead. That means clear policies, minimum standards, defined decision rights, and a shared definition of what counts as significant risk. His framing is the critical few versus the important many. The practical test is when a regulatory inquiry arrives, can your local person tell whether it carries real risk or is routine? A question from the FDA may land in a very different tone than one from HSA in Singapore. Set the guardrails, then equip people with the skills to interpret and know when to escalate. Otherwise, you’ve built a control tower and called it a hybrid.

Fragmentation and inconsistent execution are what regulators actually find. Julio’s emphasis is on the consistency of application in risk management, not on the consistency of decisions, a sharper distinction than most people draw. He’s a firm believer in qualifying people, and he sees that mattering more, not less, as tools proliferate. Policies need to describe what the system is, how it can be used, and what it can’t be used for.

Automating a broken process gives you a faster broken process. One of the most common pitfalls he named: a company doesn’t really have a process, but now it has a tool, so it wires the weak process into AI and expects improvement. The process stays broken. Fix it first, then look at where the tools fit.

High-performing organizations share a model rather than passing handoffs. When quality, IT, and data science operate in silos, innovation stalls. Each brings something the others need: quality brings the risk framework and process knowledge, IT brings architecture and security, data science brings models and analytics. They have to be in it from the start. Innovation gets held up when one group runs ahead without the others, then has to come back, data science building something impressive without accounting for infrastructure, security, or patient risk. He also flagged shared vocabulary as an underrated point of failure, since what you call things can quietly derail alignment.

Develop two capabilities: risk management and enough technical literacy to ask hard questions. Julio’s advice for quality leaders is to pair deep risk management skill with what he calls knowing enough to be dangerous. Understand the technology well enough to ask real questions, because if you don’t, you’ll hear things and follow them on trust. His counter-principle is the old quality standard: trust but verify. He spends real time learning and builds agents himself just to understand what the tools can do. He was blunt that you can’t be a PowerPoint leader. You need to know the quality system and the regulation. He praised QMSR for bringing ISO 13485 and ISO 14971 together into real application. You don’t need every detail; that’s what an organization is for, but you need enough.

You know you’ve reached “dangerous” when people can’t answer you immediately. This was the sharpest exchange in the conversation. Julio’s test: if he asks questions and people respond right away, he hasn’t asked anything challenging yet. When someone says “I hadn’t thought about that,” he’s adding value rather than checking boxes. He extends the same logic to leadership development, telling people they discover the limits of their authority by crossing a boundary and getting the slap on the wrist. Until then, you’re operating in the safe zone, and you don’t actually know where your edge is.

You’re on an escalator going down. Nick described the shift in how continuous learning feels: he used to read, attend conferences, and take training and come away feeling he’d gained an advantage. Now the same effort feels like keeping pace. Julio’s analogy was better. It’s an escalator coming down. The moment you stop, you go backward. Both agreed the useful response is accepting that this is now the condition rather than a personal failing. Everyone feels the same way. Don’t be hard on yourself, and don’t stop climbing.

Comfort with vulnerability is part of the job. Julio’s own framing as head of quality is that he knows he’s vulnerable every hour, and that isn’t catastrophic; it’s accurate. There’s no process so solid that nothing can go wrong. Things go wrong when you’re comfortable, so the working question becomes what could go wrong tomorrow that you can prevent today.

What regulators will expect, starting now rather than in three years. Julio’s view is that “looking ahead” is really describing today. Companies need structured AI governance built into the quality system, with boundaries even if AI is used widely elsewhere in the business. If a company moves fast on AI, the governance has to keep pace. Monitoring matters: how many agents, what utilization, how people are making decisions. Change management matters because the policy you write today may not hold in six months as new tools arrive. Accountability and clear intended use must be explicit across the organization, with a risk-based split between what you can use a research assistant for without heavy validation and where a decision about a product is being made—decisions AI does not make. The concrete first step he recommends is to inventory your AI use cases and classify them by risk, so the organization can see what it can do, how it should do it, and what it probably can’t. And the scope extends past quality systems into patient information, data, and HIPAA. Then training, repeatedly. Your best people today may not be your best people in three to five years if you don’t train them, and that includes training yourself.

His closing advice. Use AI today responsibly within a framework. The framework already exists under QMSR and ISO 13485, and AI use aligns to it. Train yourself and your teams, and don’t underestimate how much a quality leader needs to genuinely understand what they’re walking into.

One thing to bring back to your team

Inventory your AI use cases and classify them by risk.

Most organizations can’t answer basic questions about their own AI exposure: how many tools are in use, by whom, for what, and where a human is genuinely making the decision versus rubber-stamping an output. Until you have that inventory, your governance is theoretical.

Then ask the harder cultural question underneath the whole conversation. The last time something minor went wrong in your organization, did leadership treat it as a slap on the wrist or as a catastrophe? Because as Julio put it, one overreaction to a low-risk event is enough to make a team risk-averse, and a risk-averse quality organization won’t innovate no matter what your policy says.

Julio Salwen is SVP and Chief Quality Officer at MiniMed, the diabetes company formerly part of Medtronic, where he shapes and executes global quality strategy across the full product lifecycle and advises the CEO, executive leadership, and board on quality, compliance risk, and patient safety. An engineer by training, he has more than 35 years of experience in the pharmaceutical, medical device, and IVD industries, with responsibilities spanning the product lifecycle, manufacturing, engineering, logistics, planning, and quality management. Before MiniMed, he was VP of Quality for Medtronic's Diabetes Operating Unit. Prior to that, he spent seven years at Abbott as Divisional Vice President of Quality Assurance and Technical Services for Abbott Point of Care and Global Head of Quality for Abbott Molecular. He spent more than two decades at Baxter Healthcare in roles including Director of Quality for Global Medical Products and Director of Quality for Medication Delivery EMEA, based in Puerto Rico, Switzerland, and the United States.

Connect with Julio on LinkedIn here.

Who is The FDA Group?

The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations.

With over 3,750 resources worldwide, over 325 of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee.

Here’s why 17 of the top 20 life science firms access their consulting and contractor talent through us:

• Resources in 75 countries and 48 states.

• 26 hours average time to present a consultant or candidate.

• Exclusive life science focus and expertise.

• Dedicated account management team.

• Right resource, first time (95% success).

• 97% client satisfaction rating.

Talk to us when you're ready for a better talent resourcing experience and the peace of mind that comes with a partner whose commitment to quality and integrity reflects your own.

Subscribe to The Life Science Rundown:

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Check out our newly launched AI-powered QMS audit tool, AICA (the Audit Intelligence Compliance Assistant).

Julio and Nick get into why building for the auditor is the wrong instinct, how to introduce AI where the risk is genuinely low, why one overreaction makes an organization risk-averse, and what regulators will expect from AI governance.

A few of Julio's key takeaways:

• Regulatory confidence means decisions you can explain, not just documentation you can produce

• Stop asking what the auditor will think. Control the real risk and compliance follows as a byproduct

• You can't ChatGPT compliance. Turning people loose on AI without defined intended use is a serious unintentional risk

• Start AI where risk is low, research and drafting, and build confidence from there. Decisions stay with qualified professionals

• Drop the control tower. Hybrid governance needs standards, decision rights, and escalation, not central control of everything

• Automating a broken process just gives you a faster broken process

• Quality leaders need risk management depth plus enough technical literacy to ask hard questions

• Inventory your AI use cases and classify them by risk. That's the practical starting point

About Julio Salwen
Julio Salwen is SVP and Chief Quality Officer at MiniMed, the diabetes company recently spun off from Medtronic. An engineer by training with over 35 years in pharma, medical devices, and IVD, he previously served as VP of Quality for Medtronic's Diabetes Operating Unit, Divisional VP of Quality for Abbott Point of Care, and Global Head of Quality for Abbott Molecular, following more than two decades at Baxter Healthcare across Puerto Rico, Europe, and the US.

About The FDA Group
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

AICA, the Audit Intelligence Compliance Assistance, is a patent-pending AI-powered compliance auditing tool we launched this year that analyzes all of your QMS documentation at machine speed.

It eliminates the sampling and blind spots common with fully manual document reviews. Upload your documents and get results the same day. If you’re new to AICA, learn more about it at aica.thefdagroup.com. Get a personalized demo here, or watch our intro below.

We’ll be recording a detailed session on AICA later this month. The short demos we’ve published so far (here and here) cover AICA’s workflow at a high level. This one will go deeper, and we want the questions in it to come from you.

Joining the session will be Eric Boyd, who leads the AICA client team, Alan Greathouse, our Senior Director of Quality and Service Assurance, senior quality consultant Neal Siegel, and Diana Mankevych from EPAM, our development partner on the tool.

If there’s anything you’ve been wondering about the tool, use the form below to ask, and we’ll address it during the session.

Submit a question about AICA

Any and all questions are welcome. If you’re curious about something, others probably are, too!

What we’ll cover in the deep dive

A few things we’ll tackle in the session you’ll be able to watch on-demand whenever you want:

• The problem the tool was built for, including what FDA inspection data says about written procedures as a category of citation, and what document sampling does and doesn’t catch.

• A live walkthrough. Scoping an audit, uploading documentation, the heat map, and how observations map back to specific CFR sections.

• How AICA was built. Neal, who will be joining us, worked on tuning AICA’s analysis against real quality documentation, and he’ll talk about how its accuracy changed over the course of that work. (We spoke to him about that already here.) Diana will cover how EPAM’s developers and our regulatory people worked together.

• Where AICA differs from a general-purpose AI model, particularly in gaps that only show up when procedures are read against each other rather than one at a time.

• A panel Q&A answering your questions, the accuracy framework, data security, the human review step, and what’s next on the roadmap.

Stay tuned for more!

Read our other AICA articles:

• A Warning Letter Citation AICA Likely Would Have Flagged

• Eric Boyd Introduces the Latest Version of AICA in 3 Minutes

• What AICA Actually Sees When It Looks at Your Procedures

• AICA's Security Architecture: What Your IT Team Needs to Know

• A Few Use Cases for AICA

• Your AICA Questions, Answered

• AICA is Officially Live — Here's Everything You Need to Know

Have questions or want to get a demo?

Want to see whether AICA fits your team? Visit aica.thefdagroup.com to learn more and get in touch. We’re onboarding teams to the tool right now.

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Ask most companies when they engage regulatory expertise and the answer is some version of “when we were ready to file.” The 510(k) is coming, the IDE needs to go out, so it’s time to bring in the regulatory people.

By then, the testing strategy is set, the protocols are written, and a fair amount of what happens next is rework nobody budgeted for.

Nick Capman recently sat down with Leland Keyt, Vice President of Regulatory Affairs and Quality Assurance at Apreo Health, to talk about what early regulatory partnership actually looks like and where the preventable costs pile up.

Leland’s spent more than 20 years in medical devices across startups, mid-size companies, and global multinationals, working on drug-eluting and bioabsorbable stents, atherectomy, pulmonary valves and assessment systems, catheters, and glucose monitoring.

She’s currently building the regulatory and quality function at Apreo, a startup running a US pivotal study for an implantable airway scaffold in severe emphysema, which means she’s living the scaling questions she’s describing.

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Leland's key insights and practical takeaways

If you’re short on time, here are the most important lessons from the discussion.

Early means concept phase, not pre-submission! Leland puts the starting line further upstream than most companies do. For her (and we agree), regulatory belongs in early development discussions and first-in-human planning. One specific payoff she flagged is intellectual property. How you describe the product in your IP narrative during concept can matter years later in a regulatory submission. That’s not a connection most teams make while they’re still sketching the device.

Most companies engage at submission when the value is in the phase before it. The typical trigger is being ready to file, whether that’s clinical work, a 510(k), etc. But you actually want regulatory input while you’re building your testing and clinical strategies, so you write protocols with the right lens for the audience reading them. Nick added a cost most teams don’t anticipate: companies frequently run more testing than they need. Early regulatory involvement isn’t only about doing things correctly; it’s about not spending money on work that adds nothing. As Leland put it, efficiency in the early stages means answering the right questions with the least amount of data.

Risk tolerance is what gets companies in trouble as they scale. This was her most repeated point! How much risk you’re carrying, and whether it’s documented and mitigated, often doesn’t surface at IDE. It surfaces at PMA, or in audits, when someone starts digging. With the transition to the ISO 13485 world via QMSR bringing risk into more of the conversation, she stressed that teams should think about design FMEAs and let that risk analysis genuinely inform testing plans (rather than treating them as parallel exercises).

What’s acceptable in development is not acceptable in commercial. The same risk calculus changes as the company matures. In development, some risks are worth taking because you’re learning. Once you’re at PMA, with a PAI and a stream of audits behind it, they aren’t! The FDA isn’t in the room early on, but they will be, and the risks you accepted in the learning phase are the ones that get examined.

Postmarket obligations are often invisible until they’re a problem. Leland described the post-approval work as happening underneath the water: reports, adverse event reporting, maintenance activities that just quietly need to occur. Getting a clearance or approval is not the finish line; you have to keep it. The failure mode she named is a resourcing one. If your team is simultaneously maintaining an approval and developing Gen 2 and Gen 3, people end up juggling, and something gets dropped. What you needed in development is not what you need at commercialization, and if you keep developing, you need to add rather than reallocate.

Rework costs more than time, and time is already expensive. For an early-stage company on seed or Series A money, the run rate makes the timeline a genuine constraint, so slowing down is costly on its own. But Leland pushed past the obvious: rework is also product cost. You built it, you tested it, something failed, now you build it again. That’s fundamentally a supply chain question. Do you have enough product to rebuild everything? And while your team is redoing that work, they aren’t doing anything else.

Regulatory shapes product decisions, not just paperwork. The instinct is to file regulatory under compliance documentation. Leland’s counterexample is geography. Different markets interpret requirements differently, and biocompatibility is where this shows up clearly. Everyone points to ISO 10993-1, but how it’s interpreted in the EU or Japan can change what you develop, what testing you run, and when you run it. Knowing that early lets you make efficient testing decisions instead of discovering the gap after the fact.

Phase transitions are your signal to reassess. Moving from development into animal work, into first-in-human, into a pilot or pivotal study, each of those is an inflection point that typically ends in a submission and sets up the next one. That’s the moment to take stock: do we have the right resources, the right expertise, or do we need something in addition to what we have? Her framing is generous and worth noting, needing new expertise doesn’t mean the expertise you have is inadequate. Nick expanded on the options, full-time hires, a high-level strategist, temporary resources, FSP or outsourcing models, and both landed on the same point: what fits one phase may not fit the next, and the answer varies by company.

Balancing speed and compliance comes down to educating the room. Decisions in this industry are rarely made by one function. Leland’s approach is to make sure everyone understands the risks being taken and the consequences across disciplines, because a decision that’s great for manufacturing might be bad for quality and worse for regulatory, and still be the right call. What you want to avoid is making the decision and discovering those consequences afterward. That only works if people were informed going in.

In board conversations, regulatory should be shaping the growth map. High growth usually means commercial expansion, and geographies vary enormously in regulatory difficulty. Leland’s role in those conversations is knowing what the board and the commercial team see as attractive markets, then providing insight on what it actually takes to get in and stay in. Her example is pointed: you may be able to enter Israel, but if it yields three cases a year, is that the best use of the effort? The requirements to maintain an approval are real, and time spent there is time not spent elsewhere.

Structure regulatory around the company’s actual goals. To be forward-looking rather than reactive, Leland argues you have to understand what matters to the company and why, then let that shape your regulatory thinking. If the goal is value add, figure out what that means from a regulatory angle. Maybe that’s a different approach to FDA, maybe it’s the Breakthrough Device pathway, maybe it’s pursuing information in another geography because it’s faster. And as company goals shift, be in those conversations, both to inform them and so regulatory leaders execute knowing why they’re doing what they’re doing.

What regulators are watching more closely now. AI topped her list, less as a technology question than a governance one: how it’s used, how it’s regulated, whether it sits inside the device or inside your development process. In Europe, she pointed to expectations around clinical evaluation reports, where it needs to be clear you’re not just using AI but interpreting the information yourself. You can use it. How you use it matters. She also flagged usability as an underrated risk on longer development timelines, where teams get deep into design verification and validation and lose the usability feedback loop, and the product needs to work well for people with genuinely different skill sets, patient or physician. On FDA’s move to ISO 13485 for QMSR, her read is that it isn’t a major shift in itself, but aspects of your audit that were previously out of bounds are now in bounds, management review among them. And she noted that FDA is using AI in its own work, which is worth understanding so you can ask the right questions and respond well.

Her one piece of advice for CEOs: build a scalable QMS. She called it the bedrock. If the foundation isn’t solid, other things fall apart easily. It runs behind the scenes, but it isn’t an afterthought. Use your quality management reviews as a genuine diagnostic on the strength of the system, and bring the right people to the table when issues come up so the decisions that follow are informed ones.

One thing to bring back to your team

Look at your next major phase transition, whatever is closest, first-in-human, a pivotal study, a submission, and ask what regulatory input you need before it rather than at it.

Then ask the harder resourcing question:

If you get the clearance or approval you’re working toward, who maintains it?

Because that work is real, it’s mostly invisible, and it doesn’t pause while your team builds the next generation. The companies that get caught are the ones that made a reasonable decision in development and never revisited it when the risk tolerance underneath them changed.

Leland Keyt is Vice President of Regulatory Affairs and Quality Assurance at Apreo Health, where she leads regulatory and quality for the company’s BREATHE Airway Scaffold, an implantable technology for severe emphysema currently in a US pivotal study. She has more than 20 years of experience in medical devices, spanning startups, mid-size organizations, and global multinationals, with work across drug-eluting stents, bare metal and bioabsorbable stents, directional atherectomy, pulmonary valves and assessment systems, catheters, and glucose monitoring systems. Before Apreo, she was Chief Product Officer at Biorithm and spent six years at Pulmonx, rising to Senior Director of Regulatory Affairs and Quality Assurance, where she navigated the FDA’s Breakthrough Device Program for the Zephyr Endobronchial Valve System and achieved PMA approval in 178 total days. She has also held regulatory and clinical leadership roles at Avinger and CardioKinetix, and supported due diligence for financing, asset acquisition, and IPO preparation. Her experience includes a successful FDA Advisory Panel for the XIENCE V Everolimus Eluting Coronary Stent System.

Connect with Leland on LinkedIn here.

Who is The FDA Group?

The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations.

With over 3,750 resources worldwide, over 325 of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee.

Here’s why 17 of the top 20 life science firms access their consulting and contractor talent through us:

• Resources in 75 countries and 48 states.

• 26 hours average time to present a consultant or candidate.

• Exclusive life science focus and expertise.

• Dedicated account management team.

• Right resource, first time (95% success).

• 97% client satisfaction rating.

Talk to us when you're ready for a better talent resourcing experience and the peace of mind that comes with a partner whose commitment to quality and integrity reflects your own.

Subscribe to The Life Science Rundown:

Apple | Spotify | YouTube | Web + Others

Check out our newly launched AI-powered QMS audit tool, AICA (the Audit Intelligence Compliance Assistant).

Leland and Nick get into why risk tolerance is the thing that catches scaling companies, the hidden costs of rework beyond timeline, how regulatory input changes product decisions across geographies, and what regulators are scrutinizing more closely now.

A few of Leland's key takeaways:

• Early means concept phase, not pre-submission. Even your IP narrative can matter years later in a submission

• Companies often run more testing than they need. Efficiency means answering the right questions with the least data

• Risk tolerance is what gets companies in trouble. What's acceptable in development isn't acceptable at PMA

• Post-market obligations happen underneath the water, and they're a resourcing problem more than a regulatory one

• Rework isn't just timeline, it's product cost and a supply chain issue

• Biocompatibility interpretation varies by geography and can change what you develop and when

• AI, usability, and management review are all getting closer regulatory attention

• Build a scalable QMS. It's the bedrock, and it isn't an afterthought

About Leland Keyt
Leland Keyt is VP of Regulatory Affairs and Quality Assurance at Apreo Health, which is running a US pivotal study for an implantable airway scaffold for severe emphysema. She has over 20 years in medical devices across startups, mid-size companies, and multinationals, previously serving as Chief Product Officer at Biorithm and Senior Director of RA/QA at Pulmonx, where she navigated FDA's Breakthrough Device Program to a 178-day PMA approval.

About The FDA Group
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

These RA/QA news rolls are available in full only to paid subscribers. Upgrade here. If you haven’t already taken our reader survey, it should only take 1 minute here.

This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.

If you haven’t upgraded to a paid subscription yet, you can do so here. Also, make sure to follow us on LinkedIn and catch the latest episodes of our podcast, The Life Science Rundown.

Here are some key items from the past couple of weeks.

💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.

Special Announcement!

We're excited to announce a very special guest coming on the Life Science Rundown podcast in September: Robert M. Califf, MD, MACC!

Dr. Califf currently serves as an Instructor in the Department of Medicine and a Member of the Duke Clinical Research Institute at Duke University, and is an Adjunct Professor of Medicine in the Division of Cardiology. He previously served as FDA Commissioner and Deputy Commissioner for Medical Products and Tobacco. Before his FDA roles, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke, director of the Duke Translational Medicine Institute, and founding director of the Duke Clinical Research Institute.

He is also a Member of the National Academy of Medicine, has served on multiple FDA advisory panels and NIH advisory committees, and has led major initiatives to improve methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI).

More details to come. If you aren't already, make sure you're subscribed wherever you listen to podcasts so you don't miss our conversation! We’ll of course post it here on the Insider Newsletter, too.

Alright, back to our regular newsroll items:

FDA Leadership and Administration

• FDA lays out a reorganization plan that takes effect October 1: The agency published a Statement of Organization, Functions, and Delegations of Authority describing plans to centralize and enhance key functions, reduce redundancies, and improve alignment. The notice arrived largely unannounced and, unlike prior versions, does not state that the Secretary approved the structure or give an effective date. Reporting from NOTUS ties it to an internal effort called “Simple Reform,” first referenced in the fiscal 2027 budget request. Under the plan, individual centers would no longer run their own administrative functions such as HR, finance, and IT. The Office of Operations would absorb those under a shared service model. Specialized field inspectors who cover specific product categories would also shift to working as generalists across industries.

• Commissioner search stays at three finalists: Bloomberg, Axios, and STAT have all reported that the search has narrowed to White House policy aide Heidi Overton, senior Pentagon health official Stephen Ferrara, and New York Cancer & Blood Specialists CEO Jeff Vacirca. The administration is separately vetting candidates for other senior roles and weighing whether to revive a coordinating leadership position eliminated in 2018 that would sit between the commissioner and the product center directors. The Atlantic published a profile of Overton describing her as a moderating influence between Make America Healthy Again goals and the mechanics of federal policymaking, and noted she is involved in drafting peptide policy.

• Four pillars posted: On July 15, Diamantas published a blog post and a new webpage setting out four guiding principles that leadership is calling the pillars of the agency’s public health mandate. The pillars track the current agenda with a few new details.

• Journal articles are not agency guidance: Diamantas gave written responses to Rep. Diana DeGette (D-Colo.) clarifying that articles published in medical journals by former Commissioner Martin Makary and former CBER Director Vinay Prasad, including their pieces on a plausible mechanism pathway and on CAR-T trial design, should not be read as agency guidance. The position is long-standing among government officials, though FDA regulators have used publications as a communications channel for years.

• Digital health staffing shifts: 💉 Annie Saha moved into a new role as director of the Division of Digital Health Outreach in the Digital Health Center of Excellence. She appears to remain on an interim assignment at CDER as associate director for data science and artificial intelligence policy. The center has not yet named a replacement for its former chief medical officer for digital health.

• CDRH recruiting reviewers for novel technologies: 💉 The device center is hiring two reviewers, one with experience in wearable sensors, artificial intelligence, and device interoperability, and one with experience in MRI safety and computational modeling. The postings follow user fee commitments to industry and public concern after last year’s reduction in force.

FDA General

• CMC readiness strategy published: 💊 The FDA released its Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development, a PDUFA VII commitment. It draws on lessons from the CMC Development and Readiness Pilot launched in 2022 and sets out the agency’s plans for fiscal 2026 and 2027.

• Three cancer trial eligibility guidances finalized: 💊 The Oncology Center of Excellence issued final guidances on laboratory values, washout periods and concomitant medications, and performance status. All three update April 2024 drafts. Material changes were few, though the final versions revise references to diversity and note the concepts may apply beyond oncology. The agency tied the release to Operation TrialBlazer.

• Seventeen peptide product-specific guidances revised: 💊 The FDA published revised draft PSGs covering 17 peptide products, including semaglutide, tirzepatide, liraglutide, teriparatide, and pegcetacoplan. The updates cover five areas: submission of recombinantly, synthetically, or semi-synthetically produced peptides as ANDAs, innate immune response testing, impurity thresholds, higher-order structure assessment, and biological activity assessment. The agency also withdrew its May 2021 guidance on ANDAs for certain highly purified synthetic peptide drug products, saying it no longer reflects current thinking, and plans to revise it this year. Comments on the Federal Register notice close on September 28.

• Fiscal 2027 user fee rates issued: 💊💉 The agency published rates for prescription drugs, medical devices, generic drugs, and OTC monograph drugs, along with outsourcing facility fees. PDUFA base revenue for fiscal 2027 is $1,515,410,160 before adjustments. One detail worth noting for device firms: the agency states in the MDUFA notice that it met its fiscal 2025 hiring goals, so registration fees will not drop for fiscal 2027.

• Nonclinical testing terminology rule reaches the White House: 💊 The Office of Information and Regulatory Affairs received a final rule titled “Nonclinical Testing Terminology” for administrative review, generally the last step before release. The rule is expected to build on the agency’s work to encourage alternatives to animal studies.

• Expedited IND pilot gets more time and a webinar: 💊 The FDA extended the comment period on its proposed Expedited Investigational New Drug pilot to August 24 and held an educational webinar on August 6. As currently structured, the pilot would recruit external research institutions to provide advice and preliminary review of sponsors’ IND submissions, and would explore rolling IND submissions.

• Three guidances land in one Friday Federal Register: 💊💉 The agency issued a new draft guidance on container closure systems and device constituent parts for biosimilar and interchangeable products, covering general and quality considerations and evaluation of the user interface for comparability to the originator. It also published a final guidance on assessing adhesion with transdermal and topical delivery systems for ANDAs, which follows three prior drafts dating to 2016, and a second revision of the draft guidance on assessing irritation and sensitization potential for those products.

• Human factors guidance takes effect August 1: 💉 CDRH posted materials from its July town hall on the new final guidance covering human factors content in device submissions, including the recording, slides, and transcript. Updates to the foundational 2016 human factors guidance are still expected. The revised eSTAR and PreSTAR templates that account for the changes are already available, with the older versions retiring August 3.

• Hemodialysis tubing guidance updated for the first time since 2008: 💉 The final guidance on 510(k) submissions for hemodialysis tubing modernizes the 2008 document without an intervening draft. Biocompatibility saw the most substantial revision: these products are now Category C for prolonged cumulative exposure, up from Category B. The agency also revamped shelf life and packaging expectations, removed a section on risks to health, and brought product code KOC explicitly into scope.

• Pediatric Advisory Committee to review 27 products: 💊💉 The committee meets September 16 to discuss postmarketing pediatric-focused safety reviews for 17 drugs and biologics and 10 devices, including Tecentriq, Veklury, and Sprycel.

• Blood supply roundtable scheduled: 💊 The FDA set its blood products roundtable for September 29, running 9 a.m. to 3 p.m. ET. Three sessions will cover current challenges to blood manufacturing supply chains, manufacturers’ views on root causes and solutions, and the role of federal agencies in building resilience.

• Model-Integrated Evidence workshop set for August 27: 💊 The half-day event covers regulatory expectations and lessons learned for population PK modeling, locally acting PBPK modeling, and oral PBPK modeling in generic submissions. It will also include an update on the ICH M15 guideline on model-informed drug development.

• Four new LEADER 3D case studies: 💊 The FDA added case studies to its rare disease drug development education program covering Benlysta (Bayesian methods), Ctexli (natural history data and a biomarker), Uplinza (a novel organ-tissue specific flare definition in the primary endpoint), and Skyclarys (a natural history study as confirmatory evidence). The repository now holds 12 case studies.

• FDA researchers test accelerated approval disclosures: 💊 A paper in Therapeutic Innovation & Regulatory Science tested how well consumers, patients, and caregivers understood different accelerated approval disclosures on a website for a fictitious leukemia drug. Adding either a physician-labeling or consumer-friendly disclosure raised awareness, but only the consumer-friendly version improved comprehension of accelerated approval concepts.

• CDER statistician on interim survival analyses: 💊 Speaking on a Friends of Cancer Research webinar, CDER statistical reviewer Shu Wang encouraged sponsors to communicate early with the agency on trial plans and to weigh drug class-specific safety concerns when planning interim looks. Draft guidance issued last year encourages sponsors to prespecify overall survival as a safety endpoint and to consider simulations when data are expected to be immature.

• CDRH sees opportunity in the Rare Disease Innovation Hub: 💉 In the FDA’s Rare Connections newsletter, CDRH Director Michelle Tarver said the center’s addition to the hub creates more opportunities for engagement on rare disease devices and that cross-center collaboration can lower development barriers. The hub is now co-chaired by all three medical product centers.

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Two stereotypes have persisted for decades: the Quality person who says no to everything, and the R&D person who shows up with a deadline they set without asking anyone.

Both are also learned, and that’s the more interesting problem we wanted to interrogate. People fall into these roles because previous experiences taught them to, and once both sides are braced for a fight, the fight is what they get, regardless of whether anyone actually disagrees about patient safety.

Nick Capman sat down with Shawn Fuller to work through why cross-functional teams default into these adversarial positions and what it takes to break the pattern. Shawn spent over 24 years at Surmodics, rising from regulatory manager to Vice President of Quality, Regulatory and Clinical Affairs, and she’s upfront about where Quality contributes to the problem.

She wanted to talk about this subject specifically because she saw plenty that could be done differently.

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Shawn’s key insights and practical takeaways

If you’re short on time, here are the most important lessons from the discussion.

Role-based identities are learned behavior, and they’re self-reinforcing. Shawn’s framing is that it’s easier to fall into learned behavior than to do anything else, and that behavior comes from years of experience. Most people have worked with someone who lived up to the stereotypical Quality roadblock, which that person would say was a response to the stereotypical R&D cowboy trying to hit a deadline they’d just announced to Quality. We carry those experiences internally, and when a similar situation comes up, we reproduce the same responses. Nobody starts out distrusting their own colleagues. You end up there.

The partnership-versus-dictatorship problem usually comes down to timing. Quality’s input typically arrives after the project has already started, which means the recommendation lands as a verdict rather than a contribution. That’s the difference between a partnership and a dictatorship, with Quality cast as the dictator. Keep patient safety as the actual goal and the posture changes, because you become willing to listen to different ways of getting there. Partnerships are easier to handle than dictatorships.

If Quality is afraid of the FDA, imagine what R&D is feeling. Shawn described her early years as a regulatory person: terrified the agency would show up, issue a 483, and hand out warning letters if the company wasn’t doing exactly what the Federal Register said. Live in it long enough and you learn FDA isn’t scary. They’re people, and they work for patient safety, which is the same thing you’re working for. Nick pushed the point further. If the Quality person signals fear, R&D takes the cue. If your posture is “I don’t want to talk to FDA about this,” the obvious question is why. He drew a useful line: don’t ask FDA what you should do, but you can share what you plan to do, particularly if you’re worried you’ve missed something.

Be ready all the time, and there’s nothing to prepare for! Shawn’s standard with her team was that she was happy when they didn’t have to prepare for an inspection, because you should always be prepared for one. Her group did well on that measure, and she’s clear about what it cost: time, effort, and a genuinely collaborative team, R&D included.

A regulatory conclusion without the reasoning behind it guarantees a fight. When Quality hands down a conclusion with no risk logic, no regulatory precedent, and no alternative pathways, you end up defending a position instead of educating your team. Shawn’s view is that R&D people can be educated too, and they’d be more comfortable in their own roles if they understood why they were doing things. People will do the right thing when they know why it’s right and how it affects the project. Some QA professionals get nervous handing over information, worried it’ll be misinterpreted, which she treats as more reason to have the educational conversation, not less. Once R&D understands the requirements, you might find room to be flexible, or reach a conclusion nobody had considered, which makes both jobs easier.

The memo-to-file versus special 510(k) question is a good test case. Shawn walked through a real trade-off: the FDA has come down hard on companies with more memos to file than they should have, on the logic that after twelve iterations you’re not making the same product anymore, and companies have received 483s for it. Her view is that a special 510(k) contains the same information a memo to file should contain. Yes, you wait 30 days. But you also avoid the later inspection that examines the process or product changes you treated as a memo to file when they warranted a special 510(k). They aren’t that expensive and don’t take as long as people assume. On where the line falls, the FDA has a solid guidance document with a flowchart, but interpretation still varies among regulatory professionals. Shawn’s approach was to have the discussion openly: if we do a memo to file we probably won’t have a problem, so why wouldn’t we do the special 510(k)? Get it out in the room so everyone inside and outside the group understands the guidance exists and how it works.

Gatekeepers create defensiveness; strategic advisors create teams. Communication is the answer to nearly every question in this territory, and how you communicate determines which role you’re playing. A gatekeeper will almost always get a defensive posture from whoever they’re working with. A strategic risk advisor isn’t working on the defensive because they’re part of the team. Shawn wants to see more QA and regulatory people move into that advisory role. Practically, it means that when R&D wants a memo to file and you want a special 510(k), you have the conversation about why each side thinks what it thinks. That gives people a sense of involvement in the decision. You may not get the answer you want, and part of the job is accepting that you won’t always get what you want, having the conversation anyway, and living with the outcome.

Quality gets brought in late partly because they haven’t earned a seat. Shawn doesn’t let her own function off the hook here. Quality is brought in after key decisions in organizations where it isn’t seen as a partner, and sometimes Quality doesn’t make the effort to understand the business process. What changes is that someone is integrated enough with the business side to carry the QA and regulatory voice into those conversations, a VP of Quality or equivalent who can say that doing it one way misses this deadline but hits the next one, or that a different approach could speed things up elsewhere. Without that access, you default to keeping people from doing the wrong thing and following every regulation to the letter. In reality, few regulations are that specific. Most allow flexibility in how you meet them, which is where precedent comes in and where the judgment actually lives.

Quality always gets the last timeline, and it never gets extended. This is the structural reason speed appears to compete with Quality. Quality sits at the end of the project and has to have everything ready for submission. When R&D misses a deadline, it hits Quality, and Quality’s timeline usually doesn’t move. So you’re perpetually playing catch-up, and when Quality says something needs more time, R&D responds that there isn’t any. R&D often doesn’t see that moving one thing affects a long chain of documents and processes, particularly anything involving validation or testing. Nick related to it from his own first job in validation: you get told they’re ready, you walk in, everyone is panicking, the money is gone, and you’re the problem before you’ve started. Shawn’s example makes the consequence concrete. Why is Quality taking so long? Because you cut three validation runs to two, there’s no third data point, and now what happens if the validation fails?

Quality plans are prescriptive, which is both the argument for and against them. Shawn is refreshingly flexible here, and admits that when she led Quality she was the one asking whether they really needed a Quality plan for a given project. The good thing about QA plans is that they’re prescriptive and help track timelines and progress. The bad thing is the same: they’re prescriptive and they document exactly where you’re not meeting your timeline. Build one carefully, with the right milestones and real follow-up, because there’s nothing worse than an inspector pulling a Quality plan and finding items that were never finished or got abandoned when a bigger project came along. Her preferred solution is to stop maintaining a separate document. Call it the project plan and include the Quality group in it, so you don’t have two plans to keep aligned.

Trust breaks down before the meeting starts. Shawn’s answer to where trust fails is that it fails before you even begin, because of how the two sides treat each other. A QA person invited to an R&D meeting walks in already defensive, because in their experience nobody listens, and it’s nice to be asked but they’ll end up doing whatever they’re told in a compressed timeline anyway. Trust is built over time. You don’t get it when you start at a new company, you can’t assume people will extend it to you, and you can’t assume you’ll extend it to them. What builds it is the working relationship. You don’t have to marry these people, as she puts it, but you work with them 40-plus hours a week on projects that can cost the company millions. Get to know the R&D group and what makes them tick. Be respectful in meetings, which means saying the thing in the room rather than complaining afterward. Most of the work of establishing trust happens outside the meeting, which means you have to put yourself out there.

Nick’s formula and the communication half of the battle. Nick returned to a formula he uses often: trust is character times competence. Both are required, or people won’t trust you. He also made a point about their highly technical field. Knowing may be half the battle, but in this space, communication is half the battle, and letting poor communication continue indefinitely isn’t sustainable. Either you burn out, someone else does, or nobody reaches their goals because everyone is hyper-focused on their own objectives instead of the team’s.

Don’t blindly defend your own team, because that’s how leaders lose trust fastest. Shawn’s answer on the leadership behaviors that shift Quality from enforcer to partner starts with the intentional culture, then adds the willingness to challenge yourself and your own group, not just everyone else. She’ll have her Quality team’s back, but she won’t blindly declare they’re right. There’s a conversation, and hopefully everyone lands in the same place. A leader who sees their own team heading down the wrong road and lets them go to protect the Quality seat will lose trust faster than through any other action. The word she keeps coming back to is genuine.

One thing to bring back to your team

Look at when quality enters your projects, and be honest about what that timing communicates.

• If Quality shows up after the technical and business decisions are locked, you’ve structurally guaranteed that its input arrives as an obstacle rather than a contribution, no matter how well anyone communicates.

• And if Quality’s timeline is the only one that never moves when upstream work slips, you’ve built the speed-versus-quality conflict into the schedule itself.

Then ask the harder question Shawn keeps circling: is your Quality group making a real effort to understand the business, or is it defaulting to enforcement because it’s never been given a seat where anything else was possible? The answer usually implicates both sides, which is precisely why it’s fixable.

Shawn Fuller is a quality and regulatory professional who spent more than 24 years at Surmodics, a supplier of components and technologies to medical device and in vitro diagnostic companies. She joined as a regulatory manager and rose to Vice President of Quality, Regulatory and Clinical Affairs, building the quality and regulatory infrastructure that supported the company’s expansion into final manufacturing across Class I, II, and III devices, customer-driven products, and internal processes. She served as both a quality and regulatory representative to R&D and as program director for a Class III medical device, taking it from concept through commercialization. She holds a BS in Biology from Wingate University and is listed on a patent for wound-packing devices. She is now semi-retired and works independently.

Connect with Shawn on LinkedIn here.

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Check out our newly launched AI-powered QMS audit tool, AICA (the Audit Intelligence Compliance Assistant).

Shawn and Nick get into the learned behavior behind the roadblock stereotype, why quality's timeline never gets extended, the memo-to-file versus special 510(k) trade-off, and the difference between a compliance gatekeeper and a strategic risk advisor.

A few of Shawn's key takeaways:

• The quality roadblock and the R&D cowboy are learned behaviors, and each one justifies the other

• A regulatory conclusion delivered without the risk logic or alternatives behind it guarantees a defensive response

• If quality is afraid of FDA, R&D takes the cue. Don't ask the agency what to do, but you can share what you plan to do

• Quality gets the last timeline and it rarely gets extended, which builds the speed-versus-quality conflict into the schedule

• Quality plans are prescriptive, which cuts both ways. Consider folding quality into the project plan instead

• Trust is built outside the meeting, over time, and you can't assume it when you walk in the door

• Don't blindly defend your own team. A leader who lets their group go down the wrong road to protect the quality seat loses trust fastest

About Shawn Fuller
Shawn Fuller spent more than 24 years at Surmodics, joining as a regulatory manager and rising to Vice President of Quality, Regulatory and Clinical Affairs. She built the quality and regulatory infrastructure supporting Class I, II, and III devices and served as program director for a Class III device from concept through commercialization. She previously held regulatory roles at Protein Design Labs and conducted transplant research at the University of Minnesota. She is now semi-retired.

About The FDA Group
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

Eric Boyd, who leads our AICA client team, recently put together a short demo built around a warning letter the FDA issued. He starts with the citation and works backward: What did the agency find, would AICA have caught it, and what would the fix have looked like inside the tool?

If this is the first you’re hearing of AICA, it’s our Audit Intelligence Compliance Assistant — an AI-powered tool we built to help Quality teams move past limited document sampling toward a system-wide view of the written quality system. It audits QMS documentation against applicable FDA regulations, flags gaps, ties each gap back to the specific regulatory expectation behind it, and produces a structured report your team can work from.

Head over to aica.thefdagroup.com and fill out our demo form to let us know you’re interested in seeing it in person. Or email Eric directly and let him know you’d like to set something up: eboyd@thefdagroup.com.

The citation

Here’s the full warning letter. The violation was a failure to establish and follow appropriate written procedures, which in this case led to contamination of drug products. It was cited under 21 CFR 211.113, control of microbiological contamination.

The point here of course, isn’t to single out this company. The finding is one we see all the time. Of the top ten citation categories issued to pharma and biologics firms last year, the two most common were procedures not in writing and the absence of written procedures altogether. Together, those two accounted for just over a third of the citations in that top ten!

What AICA is looking for

AICA reads written procedures against the regulations that apply and marks where the documentation falls short of them. Eric describes the accuracy framework behind that in plain terms. The tool is built to catch information that’s missing from a procedure, information that’s there but incomplete, and language that contradicts something written elsewhere in the system.

A failure to establish an appropriate written procedure sits in the first of those. Run the same documentation through AICA and the procedures would very likely have come back flagged for not covering enough ground to meet what the regulation expects.

Catching it in the report

Eric pulls up AICA’s final report and with the heat map, which shows where gaps concentrate across the written system. For a team preparing for an inspection, that view answers a practical question: which parts of the QMS are most likely to produce a 483 observation or a warning letter, and where should remediation start?

From there, he can quickly filter to the subpart the warning letter cited.

The report aggregates observations by CFR subpart, so the section covering control of microbiological contamination pulls together the documents AICA reviewed, the observations it made, its suggested remediation steps, and the reference material behind each one.

Double-clicking into the observations tab gets to the detail underneath. Which procedures were affected. What gap AICA found in each, and how that gap affects the health of the quality system more broadly.

What it doesn’t do

Eric closes with an important caveat. None of this guarantees a company walks out of an inspection clean, and AICA doesn’t replace auditors or the Quality team. Its output is an internal working document for remediation planning, not something handed to an investigator.

What this tool does is take the tedious part of document review off the team’s plate and give them a head start on problems before FDA sees the same thing.

Have questions or want to get a demo?

Want to see whether AICA fits your team? Visit aica.thefdagroup.com to learn more and get in touch. You can also email Eric directly at eboyd@thefdagroup.com and let him know you’d like to set something up. We’re onboarding teams to the tool right now.