The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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FDA Warning Letter Breakdown: Ineffective CAPA, 200+ Complaints, and a Corrective Action That Trending Data Flagged as Failing Three…
When a CAPA's effectiveness data shows the corrective action isn't working and the CAPA stays closed anyway, the quality system has a structural…
 • The FDA Group
Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That with John Butler
Akebia's CEO on the regulatory clarity fueling rare kidney disease investment, the reimbursement structure starving dialysis of innovation, and the…
 • The FDA Group
35:12
What Our Auditors Are Finding Lately: 8 Trends Across GMP, GLP, ISO, and CSV Audits (Q1 2026)
A look back at our recent audit reports, supplier qualifications, mock inspections, and internal assessments.
 • The FDA Group
RA/QA News Roll: Late March 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
 • The FDA Group
Embedding a Senior Consultant to Rebuild a Deviation Program at a High-Growth Biologics Site
How staff augmentation helped a biologics manufacturer move from reactive firefighting to structured deviation management.
 • The FDA Group

March 2026

Why Embedding a Senior Quality Consultant Can Be the Fastest Way to Regain Control
When you have a backlog growing faster than your team can close it, the answer isn't always hiring. Sometimes it's deploying the right person to embed…
 • The FDA Group
Guidance Breakdown: FDA Finalizes Updated Guidance on Patient Preference Information
The agency's new guidance expands the role of voluntary patient preference data across the entire device lifecycle. Here are the 12 key points we pulled…
 • The FDA Group
Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker
What it takes to align three major regulators on a single development program, and why treating ICH compliance as hard regulatory alignment is a…
 • The FDA Group
28:53
A Podcast Appearance Leads to a Warning Letter for a Biologics Developer
The FDA issued a warning letter over a TV ad and a podcast appearance by its executive chairman, citing false cure claims, missing risk information, and…
 • The FDA Group
RA/QA News Roll: Mid March 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
 • The FDA Group
An FDA Warning Letter Came With Pictures
A picture really is worth a thousand words (or in this case, a thousand lines of dense warning letter text).
 • The FDA Group
Hosting a GMP Audit: Three Places We See Preparation Gaps (and How to Close Them)
We asked a few of our auditors where they see teams fall down the most on audit logistics.
 • The FDA Group
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