Drugs
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CDER Small Business Webinar on PDUFA - December 19, 2011
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 will highlight various aspects of drug regulation.
These focused webinars will support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.
On Monday, December 19, 2011, we presented our webinar entitled CDER Small Business Webinar on PDUFA, which was an overview of all aspects of the Prescription Drug User Fee Act, which also included waiver and reduction of user fees.
Ms. Beverly Freidman was our presenter. Ms. Friedman is a pharmacist with the FDA's Center for Drug Evaluation and Research, Office of Regulatory Policy (CDER/ORP), User Fee Staff. She's been with the FDA as a project manager for over 26 years and with the CDER/ORP User Fee Staff for approximately 14 years. She’s received her B.S. in Pharmaceutical Sciences from Purdue University and MBA from the University of Maryland. She has also served with distinction as a Commissioned Corps officer in the US Public Health Service.
Web Address for viewing: https://collaboration.fda.gov/p63068644/
Download Presentation Slides: CDER Small Business Webinar on PDUFA (PDF – 64KB)
For More Information: http://www.fda.gov/smallbusinessdrugs
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