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Three Warning Letters, One Message: FDA Isn't Buying Your Corrective Actions
Mar 11
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The FDA Group
15
2
5 GMP Audit Questions That Keep Catching Pharma Teams Off Guard
Jun 26, 2025
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The FDA Group
16
1
FDA Warning Letter Breakdown: Ineffective CAPA, 200+ Complaints, and a Corrective Action That Trending Data Flagged as Failing Three…
Apr 14
•
The FDA Group
17
2
What Our Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)
Sep 10, 2025
•
The FDA Group
10
1
One Way to Interrogate "Human Error" in CAPAs
An approach to a specific, recurring problem that has held up well in practice.
24 hrs ago
•
The FDA Group
12
Eric Boyd Introduces the Latest Version of AICA in 3 Minutes
A brand new demo of the Audit Intelligence Compliance Assistant.
Jun 12
•
The FDA Group
2
1
2:59
A Few Lessons From Our Recent Audits
Five deeper problems we found across this year's audit dataset.
Jun 11
•
The FDA Group
10
1
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
6 Ways to Stay Ready for FDA Inspections
Readiness depends less on last-minute preparation and more on whether your quality system is clear, defensible, and easy to execute every day.
Jun 10
•
The FDA Group
8
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
Stop Asking Which AI Tool to Bet on in Quality and Regulatory
A primer on the argument around AI tooling we’re bringing to DIA 2026.
Jun 5
•
The FDA Group
4
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
Scoping the Real Risk of Data Integrity Issues in an Out-of-the-Box eQMS
When a clinical-stage biotech discovered its eQMS didn't have compliant audit trails and access controls, the urgent question was whether its document…
Jun 4
•
The FDA Group
3
1
50:45
Inside FDA Pre-Approval Inspections with Former Investigator, Chris Smith
What PAIs actually check, why your investigations are probably written for the wrong audience, and why fear of an inspection usually points to a…
Jun 1
•
The FDA Group
8
2
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
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
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The FDA Group
5
1
Where Your Out-of-the-Box eQMS is Probably Underbuilt
A few of the configuration gaps we see that cause compliance problems later, and where to close them.
May 20
•
The FDA Group
8
1
See all
RA/QA News Rolls
View all
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
RA/QA News Roll: Mid May 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
May 19
•
The FDA Group
3
1
RA/QA News Roll: Late April 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
May 1
•
The FDA Group
3
RA/QA News Roll: Late March 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Apr 3
•
The FDA Group
5
1
FDA News
View all
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
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The FDA Group
5
2
Podcast
View all
50:45
Inside FDA Pre-Approval Inspections with Former Investigator, Chris Smith
What PAIs actually check, why your investigations are probably written for the wrong audience, and why fear of an inspection usually points to a…
Jun 1
•
The FDA Group
8
2
30:38
TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
Your quality system looks great on paper. Can your team actually defend it?
May 18
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The FDA Group
5
1
28:53
What Keeps Good Companies From Becoming Great?
Peter Martino on vision, focus, and the discipline of doing less.
May 2
•
The FDA Group
4
19:30
What Auditors Are Actually Looking For — And the Psychology Behind How They Find It
A lead auditor's perspective on why logistics matter more than most companies think, how to handle the silence trick, and what it takes to make audit…
Apr 28
•
The FDA Group
10
1
Deep Dives
View all
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
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The FDA Group
15
1
52:34
[March 2026] MoCRA Records Access for Cosmetics, Medical Device Cybersecurity + OTC Sterility Warning Letter
Watch now (53 mins) | FDA clarifies what investigators can demand from cosmetics under MoCRA, cybersecurity requirements align with QMSR, and a Texas…
Mar 9
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The FDA Group
14
1
32:41
[February 2026] Bayesian Methods in Clinical Trials, Real-World Evidence for Devices + Warning Letter Analysis
Watch now (33 mins) | A Bayesian methodology draft guidance for clinical trial design, a finalized RWE framework for medical devices, and a Georgia…
Feb 5
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The FDA Group
6
Audit Trend Reports
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
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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
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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
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