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Prescription Drug User Fee Act Reports and Plans

The Prescription Drug User Fee Act (PDUFA) provides FDA with increasing levels of resources for the review of human drug applications. Fees that FDA collected from drug and biologics firms from 1993 to 2002 were used to reduce the time required to evaluate certain human drug applications without compromising review quality. FDA has submitted annual Performance and Financial Reports to Congress on progress in streamlining the drug review process and use of PDUFA fees. PDUFA has been amended and extended through Sept. 30, 2007. The amended act is now referred to as PDUFA III and its predecessors as PDUFA I and PDUFA II.

PDUFA Performance Reports

PDUFA Financial Reports

PDUFA Five-Year Plan

link to  Adobe Acrobat site Some of these documents are in Portable Document Format (PDF) to retain the original format. To view or print these documents, you must use the Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's website with full installation instructions.

Some of the documents on this page are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please e-mail a member of the PDUFA team located on the PDUFA Contacts page for assistance.

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