The Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.
These focused webinars support the 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.
On Tuesday July 1, 2014, CDER Small Business and Industry Assistance (CDER SBIA) hosted a webinar entitled “An Overview of FDA’s Draft Guidance - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.”
FDA published a notice in the Federal Register announcing the availability of the draft Guidance for Industry - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification. The Drug Supply Chain Security Act of 2013 requires FDA to issue draft guidance to help certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) identify suspect products, and must begin notifying FDA if it suspects it has illegitimate product in its possession on January 15, 2015. This guidance also provides information for supply chain stakeholders about how to notify FDA when they determine that they have an illegitimate product, and how to terminate that notification, consulting with FDA, should it no longer be necessary.
The purpose of this webinar was to provide an introduction and overview of FDA’s recently issued draft guidance, “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” This is the first guidance issued under the Drug Supply Chain Security Act.
Carolyn Becker, J.D.
Senior Regulatory Counsel
Office of Compliance
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
Carolyn Becker is a Senior Regulatory Counsel in the Office of Compliance, Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA) where she works on high priority enforcement issues and policy matters. Prior to that, she was a Senior Regulatory Counsel in the Office of the Commissioner where she advised the Counselor to the Commissioner on legal issues, policy and Agency activities that cut across program areas.
She first joined the Agency in 2003, working for the Associate Commissioner of Regulatory Affairs (ACRA) in FDA’s Office of Regulatory Affairs (ORA). She provided advice and counsel to the ACRA on regulatory, compliance, policy and operational issues. She also served as Acting Director of the Division of Compliance Policy in ORA’s Office of Enforcement.
From 1997 to 2003, she worked for the U.S. Department of Justice as an Assistant U.S. Attorney in Washington, D.C., prosecuting criminal cases. From 1990 to 1997, she was an Assistant State Attorney in Orlando, Florida. Ms. Becker received her J.D. from Georgetown University in 1990, and her B.A. from the University of Delaware, cum laude, in 1984.
Disclaimer: The content here is intended only to provide a summary and general overview. It is not intended to be comprehensive nor does it constitute legal advice.
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
Adobe Connect link
Presentation: Draft Guidance for Industry DSCSA Implementation: Identification of Suspect Product and Notification, July 1, 2014(PDF - 231KB)
Download Presentation Slides
FR Document: 2014-13544
Federal Register notice
Identification of Suspect Product and Notification(MP3 - 38.9MB)
Audio only file
- Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Availability
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification(PDF - 1.3MB)
CDER SBIA webinar series
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