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The Act
PDUFA IV
On 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 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
PDUFA White Paper
Nov. 10, 2005
[PDF 4.28 MB]
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Fees
Forms
User Fee Cover Sheet
Annual Reports and Plans
Meetings
Information Technology Strategic Planning Public Meeting
Oct. 19, 2007, 9:00 a.m. - 5:00 p.m.
PDUFA Public Meeting
Nov. 14, 2005
Presentations and transcript
PDUFA III Performance Evaluation Reports
Additional Information
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