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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
What Our Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)
Sep 10
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The FDA Group
9
A Few Quick Tips for CAPA System Success in 2025
Jan 22
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The FDA Group
15
FDA Uncovers Critical Manufacturing Violations at Chinese API Makers
Feb 13
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The FDA Group
18
The End-of-Year Quality Crunch: 5 Projects Demanding Extra Hands in Q4
What we’re seeing inside QA teams across the industry, and how flexible staff augmentation helps them finish the year strong.
21 hrs ago
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The FDA Group
1
Guidance Breakdown: QMS Information for Certain Premarket Submission Reviews
What device firms need to include (and update) before February 2026 to keep their PMAs and HDEs moving under the new QMSR framework.
Oct 29
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The FDA Group
RA/QA News Roll: Mid October 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Oct 17
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The FDA Group
A Pressure-Tested Playbook for FDA Inspections and Remediation with Jeff Hines
Coruna Medical's Vice President of Quality shares his 4-room inspection model and how to lead through remediation with composure, clarity, and…
Oct 17
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The FDA Group
1
52:24
What FDA’s Latest OTC Warning Letters Say About Common Failure Modes (And How to Close Them)
Three FDA warning letters posted on October 7 highlight recurring OTC gaps.
Oct 14
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The FDA Group
2
A Case Study in FDA Warning Letter Response and Quality System Overhaul
After an inspection revealed wide-ranging cGMP gaps, an OTC topical firm rebuilt its quality systems from the ground up.
Oct 8
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The FDA Group
2
FDA Warning Letter Breakdown: Data Integrity and Investigation Discipline Issues at a California OTC Drug Firm
Why CDER cited QU authority gaps, investigation shortfalls, and reformulation without validation—and what similar firms should do next.
Oct 7
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The FDA Group
5
How the Shutdown is Affecting the FDA
Another shutdown leaves the FDA balancing public health responsibilities against frozen funding. Here’s what continues, what stops, and what it means…
Oct 6
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The FDA Group
2
46:19
Leading Cross-Functional Teams from Concept to Commercialization with Marwan Fathallah
DIA Global’s CEO shares how leaders can balance innovation, rigor, and collaboration across R&D, regulatory, and commercial functions to deliver quality…
Oct 6
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The FDA Group
1
1
RA/QA News Roll: Late September 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Oct 6
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The FDA Group
1
28:35
Breaking Down E21: Including Pregnant & Breastfeeding Women in Clinical Trials with Regina Atim
How FDA/ICH’s draft E21 guidance shifts sponsors from default exclusion to risk-based inclusion—and what to do next.
Sep 30
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The FDA Group
4
48:53
Mentorship Is Leadership (in Quality): How to Pass the Torch Well with Edward Armstrong
Insights from biotech quality executive Edward Armstrong.
Sep 29
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The FDA Group
3
28:02
How to Stay Ready for the FDA (When Inspections Are Less Predictable) with Jeff Brenneman
Alora Pharmaceuticals' VP of Global Operations Quality shares how teams can sustain inspection readiness, simplify quality systems, and keep teams…
Sep 26
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The FDA Group
12
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RA/QA News Rolls
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RA/QA News Roll: Mid October 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Oct 17
•
The FDA Group
RA/QA News Roll: Late September 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Oct 6
•
The FDA Group
1
RA/QA News Roll: Mid September 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Sep 17
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The FDA Group
2
RA/QA News Roll: Late August 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Sep 2
•
The FDA Group
7
FDA News
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How the Shutdown is Affecting the FDA
Another shutdown leaves the FDA balancing public health responsibilities against frozen funding. Here’s what continues, what stops, and what it means…
Oct 6
•
The FDA Group
2
Innovative Product Approval Showcase: A Quick Mid-Year Roundup
From precision oncology breakthroughs to patient-driven diagnostics, here are some of the FDA’s most impactful approvals of 2025 so far.
Aug 8
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The FDA Group
The FDA Announces PreCheck: A Fast-Track for Building U.S. Drug Plants
A new two-phase “PreCheck” pathway could shave months off U.S. plant construction while turning early regulatory engagement into a competitive edge for…
Aug 7
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The FDA Group
5
2
Streamlining Drug Safety: A Look at FDA's New Framework for Smarter Clinical Trial Data Collection
The CDER just published a new white paper on Selective Safety Data Collection. We dissect it.
Jul 24
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The FDA Group
2
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