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Prescription Drug User Fees |
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The ActPDUFA IVOn September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 which includes the reauthorization and expansion of the Prescription Drug User Fee Act. The reauthorization of PDUFA will significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public.
Proposed PDUFA IV Recommendations Transmitted to Congress
Public meeting, Feb. 16, 2007
PDUFA IIIRecognizing 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. BackgroundPDUFA White Paper |
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Fees
FormsAnnual Reports and PlansMeetingsInformation Technology Strategic Planning Public Meeting PDUFA Public Meeting PDUFA III Performance Evaluation Reports
Additional Information |
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What's NewMore PDUFA InformationOther User Fee Information
PDUFA Contacts
Documents in Portable Document Format (PDF) retain their original format. To view or print these documents, you must use the Adobe Acrobat Reader, which is free and available directly from Adobe's Website with full installation instructions. |
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