The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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June 2025

Guidance Breakdown: Conducting Remote Regulatory Assessments (Q&As for Industry)
Remote regulatory assessments are now a permanent FDA oversight tool. (But don't call them an "inspection!")
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The FDA Group
2
5 GMP Audit Questions That Keep Catching Pharma Teams Off Guard
A few recent field notes from from our auditors and mock inspectors.
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The FDA Group
Stability Across the Lifecycle: The FDA-ICH Draft Q1 Guideline Explained
The FDA just released an extensive draft guidance document on drug stability testing that was first published earlier this year by the ICH. We break…
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The FDA Group
Guidance Breakdown: Requesting Post-Warning Letter Meetings Under GDUFA
What GDUFA III facilities must do—step by step.
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The FDA Group
FDA Launches Priority Voucher Program to Accelerate Critical Drug Reviews
The FDA announced its Commissioner’s National Priority Voucher (CNPV) program, allowing drug developers to shorten FDA review time from 10–12 months to…
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The FDA Group
FDA Warning Letter Breakdown: When DTC Dental Devices Meet the Reality of Complex Quality Management
A lengthy warning letter reveals how a dental device manufacturer's quality system unraveled—from unvalidated 3D printing to unreported patient…
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The FDA Group
Guidance Breakdown: Transfer of a Premarket Notification 510(k) Clearance
Transfer tricks and traps—a look inside FDA’s June 2025 draft Q&A on 510(k) ownership changes.
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The FDA Group
Guidance Breakdown: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
A new final guidance explains how to lock in the 8-month priority review goal for eligible ANDAs through a complete, timely Pre-Submission Facility…
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The FDA Group
RA/QA News Roll: Mid June 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 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
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