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[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
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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
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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
The FDA's One-Day Inspection Pilot Is Already Running
What we know about the new "inspectional assessments."
May 7
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The FDA Group
3
1
Guidance Breakdown: FDA Formalizes CMC Flexibilities for Cell and Gene Therapy Products Heading Toward BLA
A quick breakdown of CBER's final guidance on CMC flexibilities for human CGT product development.
May 6
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The FDA Group
8
1
How Contracted Insourcing is Making Clinical Operations More Efficient
More sponsors are embedding consultants directly into their ClinOps functions as a faster, more flexible alternative to FTEs or full outsourcing. Here's…
May 5
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The FDA Group
2
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
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