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insider.thefdagroup.comLatest Issues
[June 2026] CMC Flexibility for Cell and Gene Therapy, Finalized Human Factors Submission Guidance + a Data Integrity Warning Letter
Watch now (50 mins) | The FDA loosens CMC requirements for cell and gene therapy products, publishes a yes/no flowchart that right-sizes human factors submissions, and we break down a new warning letter.
Welcome to Insider issue #50.
What Stuck With Us at DIA 2026
We went to Philly to give a talk and came home with a notebook full of everyone else's. Here are a few things we're still thinking about.
This is a guest post from Nick Capman, President and CEO of The FDA Group.
AICA in the Quality Department: How to Actually Use it Day to Day
AICA, the Audit Intelligence Compliance Assistance, is a patent-pending AI-powered compliance auditing tool we launched this year that analyzes all of your QMS documentation at machine speed.
It eliminates the sampling and blind spots com...
Guidance Breakdown: FDA Highlights Postapproval Requirements and Resources for ANDAs
The FDA is pulling postapproval reminders out of ANDA approval letters. We break down the new reference guidance that replaces them and the obligations every approved generic has to keep on its radar.
This guidance breakdown is available i...
What the First QMSR Inspections Reveal: Familiar Problems, a Sharper Lens
The FDA says it's now run more than 100 inspections under the new rule. The top findings are not a huge surprise. Where they're surfacing is the real signal.
Today’s piece is for the device and medtech teams among us. As you know by now, t...
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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates.
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