Drugs

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - An Overview of FDA’s Guidance - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

Image of SBIA Webinar 2016

 

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our webinar series.

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

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.

Speaker:

Suzanne Barone, Ph.D.
Pharmacologist
Division of Supply Chain Integrity
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)

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

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Page Last Updated: 12/20/2016
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