martes, 22 de diciembre de 2015

Drug Information Update: CDER SBIA Webinar - CDER Direct: Wholesale Drug Distributors and Third-Party Logistics Providers (WDDs/3PLs)

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

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 and industry entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.
CDER SBIA is making available the webinar CDER Direct: Wholesale Drug Distributors Third-Party Logistics Providers (WDDs/3PLs)”. The Drug Supply Chain Security Act (DSCSA) requires prescription drug wholesale distributors and Third-Party Logistics Providers to report State licensure and other information to the FDA annually. This must be done from January 1st – March 31st each year. CDER Direct is available to report this information.
This presentation provides an overview of CDER Direct, on how WDDs and 3PLs can use CDER Direct, as well as provide answers to some frequently asked questions.
The Webinar for viewing and an audio-only MP3 file are both available at: CDER Direct
These focused 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.
For questions concerning the webinar, please contact CDER SBIA at: (866)-405-5367 | (301)-796-6707

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