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.

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Today we’re looking at a new FDA draft guidance on creating and maintaining pharma Risk Manageme…