The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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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
FDA Issues Technical Amendments to Align Device Regulations With the New QMSR, Effective February 2, 2026
Regulatory housekeeping with strategic implications: the FDA just updated 179 sections across 21 CFR to reflect the QMSR shift. February 2026 isn’t far!
 • The FDA Group
How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson
Tolmar’s Senior Vice President of Quality and Chief Quality Officer shares how teams can embed quality as a lived value—from the executive suite to the…
 • The FDA Group
43:27
CDER Warning Letters Jump 50% in FY 2025 — What That Means for Industry
FDA enforcement is accelerating. The latest data shows where the agency is focusing and what companies should be preparing for now.
 • The FDA Group
FDA Warning Letter Breakdown: 503B Failures, Insanitary Aseptic Practices, and Weak Investigations at a Sterile Outsourcing Facility
A quick case study in how weak aseptic discipline and shallow investigations unravel 503B protections.
 • The FDA Group
Guidance Breakdown: eCopy Program for Medical Device Submissions
What medical device and medtech teams need to know now that the FDA’s eCopy formatting rules are final.
 • The FDA Group
5 Underused 510(k) Practices That Make FDA Reviews Smoother, Faster, and More Predictable
Why experienced reviewers and consultants keep pushing teams to adopt these long before submission day.
 • The FDA Group
From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos Carrillo
A veteran regulatory strategist, global submission leader, and commercialization advisor walks us through how to navigate the clinic-to-commercial…
 • The FDA Group
48:45
Guidance Breakdown: Cross-Center Master Files – Where to Submit
What MF holders, sponsors, and combination-product teams need to know about the FDA’s new cross-center hosting recommendations.
 • The FDA Group
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