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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
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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
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The FDA Group
3
1
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
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The FDA Group
8
2
50:45
May 2026
[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
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The FDA Group
7
1
1:14:09
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
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The FDA Group
8
1
A Quick Note About How We Do and Don't Use AI in This Newsletter
With AI slop proliferating around us, we want to be clear about our commitment to being human-produced.
May 19
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The FDA Group
5
1
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
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
•
The FDA Group
5
1
30:38
Embedding a Clinical QA Consultant for Phase 3 QMS Development
Six months to inspection-ready. Here's a look inside the clinical QMS build that took a small sponsor from Phase 2 success to Phase 3 first patient…
May 14
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The FDA Group
4
1
5 Things We Commonly Find in SOP Gap Analyses
Specific findings differ from one procedure to another, but a few overarching gaps tend to be the same.
May 12
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The FDA Group
9
1
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