Generic Drug User Fee (GDUF) Public Meeting: September 17, 2010

The Food and Drug Administration (FDA) is announcing a public meeting to gather stakeholder input on the development of a generic drug user fee program. The number of human generic drug applications awaiting FDA action and the median review times for generic drug applications have increased in recent years. A user fee program could provide necessary supplemental funding, in addition to current Congressional appropriations, to allow for the timely review of such applications. Although the President’s Fiscal Year (FY) 2011 budget includes generic drug user fees, new legislation would be required for FDA to establish and collect user fees under such a program. As FDA begins negotiations with the regulated industry about generic drug user fees, FDA will hold a public meeting to gather the public’s input on such a program. Registration for the public meeting will close on September 9, 2010 and the docket will be held open for submission of comments until October 17, 2010. For those who have not pre-registered, walk in registration will be permitted on a first come, first serve basis.

Date:       September 17, 2010

Time:       9:00 a.m. - 5:00 p.m.

Location:  Hilton Washington DC/Rockville and Executive Meeting Center
               1750 Rockville Pike
               Rockville, MD 20852

• Federal Register Notice
• Agenda (PDF - 11KB)
• Attendee Meeting List (PDF - 29KB)
• Remarks (PDF - 18KB)
• Transcript: Friday, September 17, 2010 (PDF - 407KB)
• December 20, 2010: Update (PDF - 19KB)