CDER SBIA Webinar - An Overview of FDA’s Guidance - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

CDER is making available the pre-recorded webinar:

"An Overview of FDA’s Guidance - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification."

The webinar discusses the three main topics of the guidance: first, the identification of a suspect product, and recommendations how to identify a suspect product; second, the concept of high risk of illegitimacy; and third, the processes for notifying FDA of an illegitimate product or product with high risk of illegitimacy and for requesting termination of a notification which includes using Form FDA 3911.

Resources for You:

• Webinar
• Webinar Slides (PDF - 227KB)
• Federal Register Notice
• Guidance (PDF - 146KB)
• Form 3911

For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707