FDA To Discuss "PDUFA III" Agenda At September Meeting
Executive Summary
FDA is soliciting public input into its goals for reauthorization of the Prescription Drug User Fee Act.
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The design of FDA's user fee system should encourage attention to the entire life cycle of a product, Center for Devices & Radiologic Health Director David Feigal, MD, said at the Food & Drug Law Institute meeting in Washington, D.C. June 5.
FDA User Fees Could Fund Responses To DTC Ads, AARP Says
The federal government should sponsor public information campaigns to supplement the information supplied by direct-to-consumer advertising of pharmaceuticals, an AARP Public Policy Institute "issue paper" on DTC ads states.
User Fee Revision Reduces Expected CDER Staffing Increases By 139 FTEs
A revision of FDA's estimated revenues from user fees will reduce the expected additions in staff to the Center for Drug Evaluation & Research to 40% of previous estimates.