Reporting CMC Post-Approval Changes

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Reporting CMC Post-Approval Changes, Proactively Addressing the Root Causes of Medical Device Recalls + Warning Letter Breakdown

We explore a new guidance clarifying post-approval changes to disposable materials, examine new research into the root causes of device recalls, and break down a validation Warning Letter.

The FDA Group

Dec 01, 2022

∙ Paid

Welcome to Insider issue #8.

And welcome to the 91 new life science professionals who joined last month.

Today we’re looking at a new FDA draft guidance on creating and maintaining pharma Risk Manageme…

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The FDA Group