U.S. Food and Drug Administration

Prescription Drug User Fees

The Act


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


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.


PDUFA White Paper
Nov. 10, 2005
[PDF 4.28 MB]



User Fee Cover Sheet

Annual Reports and Plans


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

What's New

More PDUFA Information

Other User Fee Information

PDUFA Contacts

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