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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!
Dec 10
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The FDA Group
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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…
Dec 9
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The FDA Group
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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.
Dec 9
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The FDA Group
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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.
Dec 8
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The FDA Group
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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.
Dec 4
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The FDA Group
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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.
Dec 3
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The FDA Group
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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…
Dec 2
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The FDA Group
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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.
Dec 2
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The FDA Group
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RA/QA News Roll: Late November 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Dec 1
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The FDA Group
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November 2025
FDA Warning Letter Breakdown: High-Risk Component Testing, Toxic Ingredients and Water System Failures at a Homeopathic Oral Liquid…
CDER cites missing DEG/EG and methanol testing, unvalidated suppliers and an uncontrolled water system at a homeopathic firm.
Nov 21
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The FDA Group
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How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria Vassileva
DIA’s Chief Science & Regulatory Officer explains how FDA and global counterparts are adopting AI for efficiency while preserving scientific rigor…
Nov 18
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The FDA Group
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51:29
RA/QA News Roll: Mid November 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Nov 17
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The FDA Group
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