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Three Warning Letters, One Message: FDA Isn't Buying Your Corrective Actions
Mar 11
•
The FDA Group
15
2
FDA Warning Letter Breakdown: Ineffective CAPA, 200+ Complaints, and a Corrective Action That Trending Data Flagged as Failing Three…
Apr 14
•
The FDA Group
18
2
5 GMP Audit Questions That Keep Catching Pharma Teams Off Guard
Jun 26, 2025
•
The FDA Group
16
1
The ICH Just Released Its Overhauled Stability Guideline for Consultation
Apr 22, 2025
•
The FDA Group
8
30:29
Why Quality and R&D Default to Conflict (and How to Fix It)
A former VP of Quality on the learned behavior behind the roadblock stereotype, why Quality usually gets the last timeline, and what it takes to be a…
17 hrs ago
•
The FDA Group
11
1
Why Quality and R&D Default to Conflict (and How to Fix It)
Why do quality and R&D fall into adversarial roles even when both are working toward patient safety?
18 hrs ago
•
The FDA Group
30:29
A Warning Letter Citation AICA Likely Would Have Flagged
A quick look at how AICA might have caught the indicators of a real FDA warning letter citation in its reports.
Aug 3
•
The FDA Group
7
2
3:15
[July 2026] ANDA Postapproval Requirements Consolidated, a Device Warning Letter About Broken Feedback Loops + Aseptic Filling Basics…
Watch now (42 mins) | The FDA pulls the boilerplate out of ANDA approval letters and puts it in one place and cites a firm for a quality system that saw…
Jul 31
•
The FDA Group
17
1
41:45
Consultant Spotlight: What a Career in 510(k)s Teaches You About Reading the FDA with Trey Thorsen, MS, RAC
How a chemistry major became a 510(k) specialist, and what he's learned about getting devices through the FDA.
Jul 29
•
The FDA Group
7
1
12:24
7 More Takeaways From Our Q2 2026 Audit Data
We extract a few more important insights from our Q2 audit reports.
Jul 28
•
The FDA Group
12
1
What Our Auditors Are Finding Lately: 7 Trends Across GMP, GLP, GCP, and Device Work (Q2 2026)
A quarter's worth of supplier qualifications, mock inspections, vendor re-quals, and internal audits, read back to back.
Jul 23
•
The FDA Group
8
1
RA/QA News Roll: Mid July 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jul 21
•
The FDA Group
5
1
Closing the DSCSA Investigation Gap
Suspect-product handling asks distribution and dispensing teams to run the kind of investigation a GMP quality unit runs every day. On that side of the…
Jul 20
•
The FDA Group
5
1
49:13
Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar
The head of the American Society for Quality on why AI is now a leadership problem, not a technology one, and what executives owe their people through…
Jul 14
•
The FDA Group
7
53:41
Growing Your Career in RA/QA with Jessica Beaver
A conversation about the questions every regulatory and quality professional eventually has to answer for themselves.
Jul 10
•
The FDA Group
2
Where Our Auditors Are Finding QMSR Compliance Gaps
The QMSR readiness work our teams are doing on client QMS projects keeps surfacing the same handful of exposures.
Jul 8
•
The FDA Group
8
49:13
Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar
A special one for us: we sat down with Sid Bhatnagar, CEO of ASQ, the American Society for Quality.
Jul 3
•
The FDA Group
1
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RA/QA News Rolls
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RA/QA News Roll: Mid July 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jul 21
•
The FDA Group
5
1
RA/QA News Roll: Late June 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jul 3
•
The FDA Group
3
RA/QA News Roll: Mid June 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jun 18
•
The FDA Group
5
1
RA/QA News Roll: Late May 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jun 5
•
The FDA Group
4
FDA News
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House Appropriators Tell FDA to Accelerate its IND Sign-Off
Congress wants faster entry into early-phase trials as drug development keeps shifting toward China and Australia.
Jun 11
•
The FDA Group
7
1
A Quick Explainer on the FDA's Leadership Shakeups
There's been a lot happening. Here's a simple guide for catching up with recent personnel changes.
May 20
•
The FDA Group
5
1
The FDA's One-Day Inspection Pilot Is Already Running
What we know about the new "inspectional assessments."
May 7
•
The FDA Group
3
1
More OMQ Letters After FDA Inspections? Don't Treat Them as Noise
We're hearing that manufacturers are getting more post-inspection mail from CDER. Here's what the letters actually mean for your next inspection.
May 4
•
The FDA Group
5
2
Podcast
View all
30:29
Why Quality and R&D Default to Conflict (and How to Fix It)
A former VP of Quality on the learned behavior behind the roadblock stereotype, why Quality usually gets the last timeline, and what it takes to be a…
17 hrs ago
•
The FDA Group
11
1
49:13
Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar
The head of the American Society for Quality on why AI is now a leadership problem, not a technology one, and what executives owe their people through…
Jul 14
•
The FDA Group
7
53:41
Growing Your Career in RA/QA with Jessica Beaver
A conversation about the questions every regulatory and quality professional eventually has to answer for themselves.
Jul 10
•
The FDA Group
2
51:01
Aurion Biotech's Chief Regulatory and Quality Officer on Leading When There's No Clear Right Answer
Sterling Chung on servant leadership, the trust formula, distilling emotion out of hard decisions, and why the last thing you do for someone is half of…
Jun 19
•
The FDA Group
3
1
Deep Dives
View all
41:45
[July 2026] ANDA Postapproval Requirements Consolidated, a Device Warning Letter About Broken Feedback Loops + Aseptic Filling Basics…
Watch now (42 mins) | The FDA pulls the boilerplate out of ANDA approval letters and puts it in one place and cites a firm for a quality system that saw…
Jul 31
•
The FDA Group
17
1
50:08
[June 2026] CMC Flexibility for Cell and Gene Therapy, Finalized Human Factors Submission Guidance + a Data Integrity Warning Letter
Watch now (50 mins) | The FDA loosens CMC requirements for cell and gene therapy products, publishes a yes/no flowchart that right-sizes human factors…
Jul 1
•
The FDA Group
7
1
1:14:09
[May 2026] FDA's NAMs Validation Framework, Finalized Patient Preference Information Guidance + Clinical Thermometer Warning Letter
Watch now (74 mins) | CDER tells you how to put new approach methodologies in front of reviewers, FDA finalizes guidance on patient preference…
May 27
•
The FDA Group
7
1
56:40
[April 2026] FDA Form 483 Response Guidance, Weight Loss Device Framework + AI-Driven Device Warning Letter
Watch now (57 mins) | The FDA finalizes how to respond when inspectors hand you a 483, publishes a premarket framework for weight loss devices, and…
Apr 16
•
The FDA Group
15
1
Audit Trend Reports
View all
What Our Auditors Are Finding Lately: 7 Trends Across GMP, GLP, GCP, and Device Work (Q2 2026)
A quarter's worth of supplier qualifications, mock inspections, vendor re-quals, and internal audits, read back to back.
Jul 23
•
The FDA Group
8
1
What Our Auditors Are Finding Lately: 8 Trends Across GMP, GLP, ISO, and CSV Audits (Q1 2026)
A look back at our recent audit reports, supplier qualifications, mock inspections, and internal assessments.
Apr 9
•
The FDA Group
16
1
What Our Auditors Are Finding Lately: 10 Trends Across GMP, GCP, ISO, and GDP Audits (H2 2025)
A look back at our recent audit reports, mock inspections, gap assessments, and supplier qualifications.
Jan 23
•
The FDA Group
4
1
What Our Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)
A look back at our recent audit reports and mock inspections.
Sep 10, 2025
•
The FDA Group
10
1
AICA
View all
3:15
A Warning Letter Citation AICA Likely Would Have Flagged
A quick look at how AICA might have caught the indicators of a real FDA warning letter citation in its reports.
Aug 3
•
The FDA Group
7
2
AICA in the Quality Department: How to Actually Use it Day to Day
Where our AI-powered auditing tool fits in the everyday work of a Quality team.
Jun 25
•
The FDA Group
3
1
What AICA Actually Sees When It Looks at Your Procedures
A conversation with our contributor consultants on the one question AICA is built to answer, and the dimensions of compliance work it deliberately…
Jun 9
•
The FDA Group
3
1
AICA's Security Architecture: What Your IT Team Needs to Know
The technical details behind how AICA handles your data (written for the people who have to approve it).
Mar 16
•
The FDA Group
5
1
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