The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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The State of 510(k)s in 2025: Why Waiting for “Better Timing” Could Cost You
A quick conversation with Trey Thorsen, one of our senior 510(k) consultants, about what he's seeing on the frontline right now, and the advise he's…
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The FDA Group
11:12
Managing Royalties in Biotech, Pharma, and Medtech with David Marlin
A conversation with David Marlin, Co-Founder & CEO of Metacomet Systems, on the operational complexities of royalty management in the life sciences.
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The FDA Group
44:02
A Few Thoughts on How FDA's AI-Powered Risk Targeting with Elsa Could Change Inspection Readiness
The FDA says its new AI tool, Elsa, can now help pinpoint inspection targets faster and more precisely—here’s what firms might want to start thinking…
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The FDA Group
FDA Launches Its AI Tool 'Elsa' Ahead of Schedule to Enhance Agency Operations
The FDA says its new large language model–powered tool is already accelerating reviews, aiding inspections, and supporting database development as part…
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The FDA Group
RA/QA News Roll: Late May 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group

May 2025

FDA Warning Letter Breakdown: Four Letters Reveal Cascading Control Failures Across Device Firms
The FDA's CDRH recently warned four medical device makers about a range of failures in procedures and processes.
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The FDA Group
Are Workforce Cuts Slowing Down the FDA? Here's What Our Consultants Are Seeing
Anecdotes from the field reveal a complex, uneven picture of how FDA’s internal upheaval is playing out in practice at the moment.
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The FDA Group
Our 7 Takeaways from the New MAHA Report
The White House published its MAHA commission report, outlining key priorities of the Trump administration for transforming the US healthcare system and…
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The FDA Group
FDA Warning Letter Breakdown: A Quality System Collapses at a Blood Collection Device Manufacturer
A recently posted warning letter reveals systemic failures—and critical lessons—for device manufacturers on validation, design controls, and supplier…
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The FDA Group
GMP Compliance in 503B Compounding Pharmacies: Navigating the Challenges with Jesse Gillikan
A conversation with Jesse Gillikan, President & CEO of cGMP Validation, on the evolving landscape of GMP compliance for compounding pharmacies.
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The FDA Group
24:23
RA/QA News Roll: Mid May 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
The FDA Plans to Roll Out AI for Reviews This Summer — Here's What to Know
The agency just set an "aggressive timeline" for AI Implementation after a successful pilot. Here's what to start thinking about now.
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The FDA Group
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