The FDA Group's Insider Newsletter
The FDA GroupThe latest news and exclusive analysis across the FDA-regulated industries from former FDA professionals and industry experts. Save time gathering the critical industry intelligence you need to act on.
| Platform |  | Pricing | Freemium | Publishes | Daily |
|---|---|---|---|---|---|
| Issues | 407 | Subscribers | Read | insider.thefdagroup.com |
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Latest Issues
Recent posts by this newsletter. Browse the email archive.
[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 sends a warning letter that signals heightened scrutiny for auto devices.
FDA Warning Letter Breakdown: Ineffective CAPA, 200+ Complaints, and a Corrective Action That Trending Data Flagged as Failing Three Quarters Before the Firm Acted
When a CAPA's effectiveness data shows the corrective action isn't working and the CAPA stays closed anyway, the quality system has a structural problem.
Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That with John Butler
Subscribe to our podcast, The Life Science Rundown, if you haven’t already.
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.
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Authors
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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates.
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