The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

Home
Notes
Archive
Leaderboard
About
GMP Compliance in 503B Compounding Pharmacies: Navigating the Challenges with Jesse Gillikan
A conversation with Jesse Gillikan, President & CEO of cGMP Validation, on the evolving landscape of GMP compliance for compounding pharmacies.
 • 
The FDA Group
24:23
RA/QA News Roll: Mid May 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
 • 
The FDA Group
The FDA Plans to Roll Out AI for Reviews This Summer — Here's What to Know
The agency just set an "aggressive timeline" for AI Implementation after a successful pilot. Here's what to start thinking about now.
 • 
The FDA Group
Tracking Major Changes at the FDA: May 13
Policy shifts, AI rollouts, reappointments, and legal backlash.
 • 
The FDA Group
Unannounced FDA Foreign Inspections Expand as Administration Pushes Domestic Manufacturing
Domestic manufacturing is about to get fast-tracked while foreign facilities face surprise inspections. Are you ready?
 • 
The FDA Group
RA/QA News Roll: Late April 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
 • 
The FDA Group

April 2025

A Closer Look at the Common Prereview Medical Device Compliance Pitfalls an FDA Panel Cited at MedCon
How to avoid compliance issues around software change documentation, design creep, and marketing beyond intended use
 • 
The FDA Group
Tracking Major Changes at the FDA: April 25
The agency faces database setbacks, leadership changes, and legal challenges as staff cuts reshape regulation and enforcement.
 • 
The FDA Group
FDA Warning Letter Breakdown: Quality Systems Fail at a Medical Device Manufacturer
A long list of deficiencies offers a ton of lessons for device firms on what the FDA is finding and citing.
 • 
The FDA Group
The ICH Just Released Its Overhauled Stability Guideline for Consultation
Here's a detailed breakdown plus a few questions for self-assessment.
 • 
The FDA Group
15 Audit Questions That Could Save You From an FDA Warning Letter (Part 3)
In our final installment, we explore five overlooked—but frequently cited—compliance risks drawn from recent FDA enforcement actions.
 • 
The FDA Group
Tracking Major Changes at the FDA: April 18
A leaked HHS budget reveals major FDA cuts, layoffs delay pediatric policy meeting, and biotech firms report review slowdowns.
 • 
The FDA Group
© 2025 The FDA Group, LLC
Privacy ∙ Terms ∙ Collection notice
Start writingGet the app
Substack is the home for great culture