The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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RA/QA News Roll: Mid September 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
Guidance Breakdown: Alternative Tools for Assessing Drug Manufacturing Facilities Identified in Pending Applications
The FDA explains how it'll use alternative tools—§704(a)(4) records requests, RIEs, and inspections supported by remote SMEs—to assess facilities named…
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The FDA Group
A Few More Insights From Our Recent Audit Reports
Following up on our most-read trends report with fresh takeaways from the same dataset.
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The FDA Group
What Our Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)
A look back at our recent audit reports and mock inspections.
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The FDA Group
Guidance Breakdown: E6(R3) Good Clinical Practice (GCP) Guidance for Industry
The FDA’s adoption of ICH E6(R3) marks a major shift in GCP, moving from checklist compliance to risk-based, quality-by-design oversight.
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The FDA Group
Behind the Rejections: An Analysis of 89 FDA CRLs Reveals Why Drugs Really Fail to Get Approved
We take a look at the newly released Complete Response Letters that expose the systematic barriers preventing new drugs from reaching patients.
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The FDA Group
How to Build High-Performing Quality Teams with Marcus Gesner
embecta’s VP of Global Quality opens his playbook for building high-performing teams through the right incentives, hiring, onboarding and clear…
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The FDA Group
49:35
RA/QA News Roll: Late August 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group

August 2025

FDA Warning Letter Breakdown: Inside a GLP Collapse at a Chinese Testing Facility
Data integrity problems reveal what happens when compliance becomes theater and why the firm voluntarily suspended all FDA-related non-clinical testing…
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The FDA Group
Inside FDA’s 2024 Quality Report: What RA/QA Teams Need to Know
Foreign inspections surge, warning letters hit a five-year high, and API supply chains face mounting risk—what the FDA’s latest pharma quality report…
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The FDA Group
The 4 Cs of MedTech Leadership with Sean Gallimore
Sean Gallimore is an executive consultant working with early-stage medtech startups. His previous work has included roles with Medtronic, Johnson …
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The FDA Group
54:16
RA/QA News Roll: Mid August 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
 • 
The FDA Group
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