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The FDA Group's Insider Newsletter

The FDA Group

The latest news and exclusive analysis across the FDA-regulated industries from former FDA professionals and industry experts. Save time gathering the critical industry intelligence you need to act on.

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Latest Issues

Recent posts by this newsletter. Browse the email archive.

Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux

Subscribe to our podcast, The Life Science Rundown, if you haven’t already.

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Industry Pushes for Automatic Post-Inspection Meetings and Faster FDA Response Times

Representatives from the pharma industry want the FDA to commit to automatic post-inspection meetings whenever a Form 483 is issued following a Pre-Approval Inspection, and to respond to 483 responses within 15 days.

3 days ago
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15 Takeaways from FDA's QMSR Implementation Webinar

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The FDA Opens Submissions for PreCheck

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