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5 GMP Audit Questions That Keep Catching Pharma Teams Off Guard
Jun 26
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The FDA Group
15
1
What Our Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)
Sep 10
•
The FDA Group
9
1
A Few Quick Tips for CAPA System Success in 2025
Jan 22
•
The FDA Group
15
FDA Uncovers Critical Manufacturing Violations at Chinese API Makers
Feb 13
•
The FDA Group
18
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.
Dec 19
•
The FDA Group
5
1
1
RA/QA News Roll: Mid December 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Dec 17
•
The FDA Group
1
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…
Dec 16
•
The FDA Group
1
4 Drug GMP Takeaways From FDA's 2025 Warning Letters
And how QA teams should operationalize the data to strengthen compliance now.
Dec 15
•
The FDA Group
4
2
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
•
The FDA Group
4
1
43:27
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
•
The FDA Group
1
1
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
•
The FDA Group
1
1
2
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
2
2
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
•
The FDA Group
2
2
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
•
The FDA Group
8
2
48:45
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
•
The FDA Group
2
2
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
•
The FDA Group
6
2
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
•
The FDA Group
1
2
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RA/QA News Rolls
View all
RA/QA News Roll: Mid December 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Dec 17
•
The FDA Group
1
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
•
The FDA Group
1
2
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
•
The FDA Group
5
1
RA/QA News Roll: Late October 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Nov 3
•
The FDA Group
FDA News
View all
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…
Dec 16
•
The FDA Group
1
4 Drug GMP Takeaways From FDA's 2025 Warning Letters
And how QA teams should operationalize the data to strengthen compliance now.
Dec 15
•
The FDA Group
4
2
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
•
The FDA Group
1
1
2
A Quick Explainer on the Tidmarsh Drama at the FDA
A high-stakes power struggle inside the FDA has spilled into public view.
Nov 5
•
The FDA Group
2
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