FDA Finalizes Guidance on REMS Format and Content, Preparing for Expanded Device Inspection Authority + Warning Letter Breakdown
We explore FDA's expectations for the format and content of a REMS, how to prepare for more medical device inspection authority, and lessons to draw from recent high-profile FDA Warning Letters.
Welcome to Insider issue #12.
And welcome to the 213 new life science professionals who joined last month.
Today, we discuss the FDA's final guidance on the format and content of a REMS document, which outlines the expectations for manufacturers to implement specific safety measures beyond drug labeling requirements for medications with serious safety concerns.
We also touch on the FDA's newly-granted authority to request any document within a medical device manufacturer's Quality Management System (QMS) as part of their inspection and oversight powers — and how to prepare accordingly.
Lastly, we break down and draw lessons from recent high-profile Warning Letters sent to a major endoscope maker and its subsidiary for GMP issues and medical device reporting failures.
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