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U.S. Department of Health and Human Services

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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.

These focused webinars 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 October 22, 2012, the CDER Small Business Assistance Program presented a webinar entitled Generic Drug User Fee Amendment (GDUFA) – User Fees and More which provided the background and context for why GDUFA was negotiated between the FDA and regulated industry, and an overview of GDUFA's fee structure. For each of the fee types specified in the statute, we reviewed who is subject to the fee, how the fee is paid, and how the fee is calculated. General administration of GDUFA was also touched upon as relevant to the discussion.
In addition, we discussed changes and new expectations from the review perspective required under the GDUFA. We focused on the Complete Response (CR) requirement, First Cycle Post Complete Response teleconferences, and the new process when supplements which are Changes Being Effected (CBE) are found to be Prior Approval Supplements (PAS).
 
Our presenters were Donal Parks, M.B.A., M.P.M. and Thomas Hinchliffe, PharmD:
  • 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).

For More Information:

http://www.fda.gov/smallbusinessdrugs

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