The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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Consultant Spotlight: What 30+ Years of FDA, Consent Decree, and GMP Work Teaches You About Fixing Real Quality Problems
A conversation with one of our senior consultants, Neal Siegel, PhD, on system-level thinking, consent decree lessons, and what experienced quality…
 • The FDA Group
29:09
RA/QA News Roll: Mid January 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
 • The FDA Group
We Attended FDA’s QMSR Town Hall — Here’s What Device Firms Need to Know
We attended FDA’s QMSR town hall to hear directly how risk and design controls will be evaluated.
 • The FDA Group
10 Last-Minute Questions for QMSR Compliance
We're less than a month away from the QMSR. Are you ready?
 • The FDA Group
Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker
How disciplined knowledge transfer, risk management, and communication prevent costly delays as products scale.
 • The FDA Group
35:24
Guidance Breakdown: Processes and Practices Applicable to Bioresearch Monitoring (BIMO) Inspections
What sponsors, CROs, investigators, IRBs, and nonclinical labs need to know about how FDA conducts BIMO inspections, and how to prepare for them.
 • The FDA Group
FDA Drug Reviews Held Steady in 2025 Despite Historic Staffing Losses
A new data study reveals what we've seen firsthand: the FDA isn't slowing down reviews even after trimming its staff significantly.
 • The FDA Group
Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin
ISPE’s Mike Martin shares how automation, culture, and lifelong learning are redefining what it means to work in pharma.
 • The FDA Group
42:34

December 2025

FDA Warning Letter Breakdown: Complaint Backlogs, CAPA Blind Spots, and Risk Management Gaps at an Implantable Device Manufacturer
How unresolved quality system fundamentals cascade across complaints, CAPA, and design risk.
 • The FDA Group
RA/QA News Roll: Mid December 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
 • The FDA Group
FDA Removes a Major Barrier to Using Real-World Evidence in Regulatory Reviews
The agency says it will now evaluate real-world evidence on a case-by-case basis, removing long-standing requirements for identifiable patient-level…
 • The FDA Group
4 Drug GMP Takeaways From FDA's 2025 Warning Letters
And how QA teams should operationalize the data to strengthen compliance now.
 • The FDA Group
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