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| Platform |  | Pricing | Freemium | Publishes | Daily |
|---|---|---|---|---|---|
| Issues | 536 | Founded | 5 years ago | Last Issue | 3 days ago |
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insider.thefdagroup.comLatest Issues
Why Quality and R&D Default to Conflict (and How to Fix It)
Subscribe to our podcast, The Life Science Rundown, if you haven’t already.
Two stereotypes have persisted for decades: the Quality person who says no to everything, and the R&D person who shows up with a deadline they set without asking a...
Why Quality and R&D Default to Conflict (and How to Fix It)
Why do quality and R&D fall into adversarial roles even when both are working toward patient safety? Shawn Fuller, who spent 24 years at Surmodics and rose from regulatory manager to VP of Quality, Regulatory and Clinical Affairs, is candid...
A Warning Letter Citation AICA Likely Would Have Flagged
The Audit Intelligence Compliance Assistant, or AICA, is a patent-pending AI-powered compliance auditing tool that analyzes all of your QMS documentation at machine speed. Learn more and get a demo at aica.thefdagroup.com.
Eric Boyd, who l...
[July 2026] ANDA Postapproval Requirements Consolidated, a Device Warning Letter About Broken Feedback Loops + Aseptic Filling Basics Ignored
Watch now (42 mins) | The FDA pulls the boilerplate out of ANDA approval letters and puts it in one place and cites a firm for a quality system that saw the hazard in one file and acted like it hadn't in another.
Welcome to Insider issue #...
Consultant Spotlight: What a Career in 510(k)s Teaches You About Reading the FDA with Trey Thorsen, MS, RAC
Once in a while, we want to showcase the incredible people in our consulting group by digging under the CV to hear their stories and what motivates them to do the work they’re doing across the life sciences. A few months back, we showcased...
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