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Three Warning Letters, One Message: FDA Isn't Buying Your Corrective Actions

Mar 11 • The FDA Group

FDA Warning Letter Breakdown: Ineffective CAPA, 200+ Complaints, and a Corrective Action That Trending Data Flagged as Failing Three…

Apr 14 • The FDA Group

5 GMP Audit Questions That Keep Catching Pharma Teams Off Guard

Jun 26, 2025 • The FDA Group

The ICH Just Released Its Overhauled Stability Guideline for Consultation

Apr 22, 2025 • The FDA Group

11:47

Guidance Breakdown: eSTAR Is Coming for PMAs

Our consultant contributor Jesse Hart breaks down the September 2026 draft guidance that would make eSTAR the required format for PMAs.

Oct 30 • The FDA Group

8 Lessons From a Site Quality Audit With Multiple Findings

We recently ran a quality audit of a manufacturing site that turned up multiple findings, four of them repeats. Here's what the findings, and the site's…

Oct 29 • The FDA Group

Guidance Breakdown: FDA Proposes eSTAR for IDEs

CDRH and CBER issue their first draft guidance on electronic submission templates for Investigational Device Exemption applications.

Oct 28 • The FDA Group

Pharma Tech Transfer Is Knowledge Transfer, with Paige Kane, PhD, CPIP

CAI’s Paige Kane on why the “know-why” rarely makes it into the documents, and the structured questions that bring it to the surface.

Oct 26 • The FDA Group

17:58

Pharma Tech Transfer Is Knowledge Transfer

Why does tech transfer remain so hard in pharma , even when every document is neatly in order?

Oct 26 • The FDA Group

17:58

Guidance Breakdown: FDA Revises Its Small Entity Guide on IND and BA/BE Safety Reporting

The October 2026 revision adds no new requirements. What it does is confirm which guidances are current, and that two guidances your safety SOPs may…

Oct 23 • The FDA Group

4:11

The AICA Pricing Explainer: A Quick Walkthrough of How It Works

How AICA’s usage-based pricing works, which plan fits which team, and how to get started.

Oct 21 • The FDA Group

17:02

Consultant Spotlight: Jeff Jackowski on Remediation Work That Lasts

We chat with one of our consultants on his three years in Istanbul, life under a consent decree, and why the site team has to own the corrective action.

Oct 21 • The FDA Group

1:03:37

The Adoption Assumptions Hiding in Your Regulatory Strategy, with Holley Miller

A 30-year medtech marketer on the adoption assumptions hiding inside every regulatory pathway decision, and why “better” so rarely wins.

Oct 20 • The FDA Group

1:03:37

The Adoption Assumptions Hiding in Your Regulatory Strategy

Can the fastest path to FDA approval end up being the slowest path to market adoption?

Oct 20 • The FDA Group

RA/QA News Roll: Mid October 2026

Here's what's happening at FDA and across the broader life science RA/QA space.

Oct 16 • The FDA Group

41:49

[September 2026] FDA Rewrites Its Container Closure Expectations, a Dialysis Concentrate Warning Letter + an Eye Drop Maker's Repeat…

A draft guidance would replace FDA's container closure framework, a dialysate concentrate maker is cited for failed endotoxin testing, and an eye drop…

Oct 9 • The FDA Group

RA/QA News Roll: Late September 2026

Here's what's happening at FDA and across the broader life science RA/QA space.

Oct 7 • The FDA Group

RA/QA News Rolls

RA/QA News Roll: Mid October 2026

Here's what's happening at FDA and across the broader life science RA/QA space.

Oct 16 • The FDA Group

RA/QA News Roll: Late September 2026

Here's what's happening at FDA and across the broader life science RA/QA space.

Oct 7 • The FDA Group

RA/QA News Roll: Mid September 2026

Here's what's happening at FDA and across the broader life science RA/QA space.

Sep 23 • The FDA Group

RA/QA News Roll: Late August 2026

Here's what's happening at FDA and across the broader life science RA/QA space.

Sep 10 • The FDA Group

FDA News

6 BLA Submission Tips From CBER, and How to Put Each One to Work

At RAPS Convergence, an FDA regulatory project manager walked through what makes a biologics license application easier to review. Here's what she said…

Oct 1 • The FDA Group

The FDA's Expedited IND Pilot Is Live

The agency published the final design and opened applications. Eight to ten sponsor-institution pairs will be selected.

Sep 15 • The FDA Group

The FDA Just Signaled It Will Throw Out Foreign Trial Data It Can’t Verify

Four center directors signed a joint statement on GCP and foreign clinical data. No new requirements, but it’s important for how you select sites.

Sep 4 • The FDA Group

Trump Nominates Heidi Overton for FDA Commissioner

What we know so far, and what it may signal about the agency's direction.

Aug 19 • The FDA Group

Podcast

17:58

Pharma Tech Transfer Is Knowledge Transfer, with Paige Kane, PhD, CPIP

CAI’s Paige Kane on why the “know-why” rarely makes it into the documents, and the structured questions that bring it to the surface.

Oct 26 • The FDA Group

1:03:37

The Adoption Assumptions Hiding in Your Regulatory Strategy, with Holley Miller

A 30-year medtech marketer on the adoption assumptions hiding inside every regulatory pathway decision, and why “better” so rarely wins.

Oct 20 • The FDA Group

33:22

Dr. Robert Califf on What It Will Take for GLP-1s to Become a Public Health Success

The two-time FDA Commissioner on treating a patient versus improving a population's health, why access to these drugs has followed resources, and why he…

Oct 5 • The FDA Group

34:57

Is Your Biotech De-Risking or Just Delaying?

Baseimmune's CEO Kevin Walton on beachhead decisions, why accumulating supportive data can be a form of procrastination, and what’s actually getting…

Sep 18 • The FDA Group

Deep Dives

41:49

[September 2026] FDA Rewrites Its Container Closure Expectations, a Dialysis Concentrate Warning Letter + an Eye Drop Maker's Repeat…

A draft guidance would replace FDA's container closure framework, a dialysate concentrate maker is cited for failed endotoxin testing, and an eye drop…

Oct 9 • The FDA Group

41:40

[August 2026] FDA's New Rulebook for Formal Meetings, Human Factors Harmonized with QMSR + A Warning Letter Under the New Device Rule

The FDA rewrites how sponsors request meetings during drug development, folds human factors into the quality system, and posts a warning letter written…

Sep 11 • The FDA Group

41:45

[July 2026] ANDA Postapproval Requirements Consolidated, a Device Warning Letter About Broken Feedback Loops + Aseptic Filling Basics…

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 the hazard in one…

Jul 31 • The FDA Group

50:08

[June 2026] CMC Flexibility for Cell and Gene Therapy, Finalized Human Factors Submission Guidance + a Data Integrity Warning Letter

The FDA loosens CMC requirements for cell and gene therapy products, publishes a yes/no flowchart that right-sizes human factors submissions, and we…

Jul 1 • The FDA Group

Audit Trend Reports

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

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

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

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

AICA

4:11

The AICA Pricing Explainer: A Quick Walkthrough of How It Works

How AICA’s usage-based pricing works, which plan fits which team, and how to get started.

Oct 21 • The FDA Group

Elsa, HALO, and AICA: Comparing the FDA's AI Tools With Ours

The FDA's tools and those industry teams are buying solve different problems. Here's a quick look at where they actually meet, and where the comparison…

Aug 28 • The FDA Group

Ask Us Anything About AICA

We're recording an in-depth AICA session soon. Submit a question and we'll take it on during the demo!

Aug 17 • The FDA Group

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

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