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 U.S. Food and Drug Administration will hold a public meeting on April 12, 2010, to obtain comments on the Prescription Drug User Fee Act (PDUFA) program. The program authorizes user fees for FDA product reviews, which currently fund more than half of new drug review costs.
The meeting is scheduled for 9 a.m. to 5 p.m. at the Hilton Washington, D.C./Rockville Hotel and Executive Meeting Center in Rockville, Md.
The current legislative authority for PDUFA (PDUFA IV), reauthorized in 2007 by the FDA Amendments Act, will expire in September 2012. The FDA scheduled the meeting to gather input from stakeholders before the agency begins discussions with the regulated industry on PDUFA’s reauthorization.
For more information, please visit: Public Meeting on Prescription Drug User Fee Act
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