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insider.thefdagroup.comLatest Issues
The FDA's Expedited IND Pilot Is Live
The FDA just announced the final design of its Expedited Investigational New Drug Pilot and began accepting applications. Applications can be submitted until October 30, after which the FDA says it plans to review and choose participants by...
A Few Best Practices for Scheduling GxP Audits
We recently published our comprehensive guide to annual audit planning and companion checklist for Q3.
To step back and tackle GxP audit planning more generally, we put a question to our account managers who build client audit schedules an...
Reg Ops Has Been Kept in a Box. This Is the Way Out, with Carla Griffin
Subscribe to our podcast, The Life Science Rundown, if you haven’t already.
Regulatory operations professionals tend to get described by their outputs.
Hyperlinks, bookmarks, publishing, the mechanics of getting a dossier out the door cor...
Reg Ops Has Been Kept in a Box. This Is the Way Out.
As the FDA takes its first steps toward receiving clinical data in real time, what happens to regulatory operations professionals? Carla Griffin, CEO of The Sugar Water Operations Team, argues that reg ops has been kept in too small a box f...
[August 2026] FDA's New Rulebook for Formal Meetings, Human Factors Harmonized with QMSR + A Warning Letter Under the New Device Rule
Watch now (42 mins) | The FDA rewrites how sponsors request meetings during drug development, folds human factors into the quality system, and posts a warning letter written against ISO 13485 clauses in the QMSR.
Welcome to Insider issue #...
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