CDER Small Business Webinar on the Generic Drug User Fee Amendment (GDUFA) – User Fees and More - October 22, 2012
The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program 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.
- Donal directs the user fee collections staff at CDER’s Office of Management. This staff is responsible for collecting user fees under the Generic Drug User Fee Amendments (GDUFA) and the Biosimilars User Fee Act (BsUFA), both of which were authorized in the FDA Safety and Innovation Act as signed by the President on July 9, 2012.
- CDR Thomas Hinchliffe currently serves as the special assistant to the OGD Director, leading the implementation efforts in OGD for the various changes required as a result of the Generic User Fee Amendment of 2012 (GDUFA).
Learn about the Generic Drug User Fee act for fee, uhhh, free
Generic Drug User Fee Amendment (GDUFA) – User Fees and More
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Generic Drug User Fee Amendment (GDUFA) – User Fees and More(PDF - 377KB) [ARCHIVED]
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Generic Drug User Fee Amendment – User Fees and More(MP3 - 64.6MB) [ARCHIVED]
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