Prescription Drug User Fees


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Prescription Drug User Fees

	The Act -- PDUFA III Recognizing the necessity of reauthorizing PDUFA before the end of FY 2002 to assure continuity of operations, Congress enacted the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which includes the Prescription Drug User Fee Amendments of 2002 (PDUFA III) reauthorizing user fees through FY 2007. The President signed PDUFA III into law on June 12, 2002. Background Overview PDUFA Law Performance Goals PDUFA III	Fees Payment Procedures/Rates for Fiscal Year 2005 Federal Register Aug. 2, 2004 PDF 58 KB Payment Procedures/Rates for FY 2004 Federal Register Aug. 1, 2003 PDF 46.6KB Payment Procedures/Rates for FY 2003 Federal Register Aug. 2, 2002 PDF 46.6KB Annual Reports and Plans Performance Financial Five-Year Plans PDUFA Contacts Agency and Center Contacts	What's New Establishment of Prescription Drug User Fee Rates for Fiscal Year 2005 (Federal Register Aug. 2, 2004) (PDF 58 KB) FY 2003 Financial Report to Congress (PDF 303 KB) Center PDUFA Pages Drugs Biologics Other FDA User Fees MDUFMA MQSA

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The Act -- PDUFA III