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In 1992, Congress passed PDUFA, authorizing FDA to collect fees from companies that produce and submit applications for marketing for human drug and biological products. The original PDUFA had a five-year life; it ended in 1997, the same year Congress passed the FDA Modernization Act (FDAMA). FDAMA contained a five-year reauthorization of PDUFA (PDUFA II) that ended on September 30, 2002. When Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), it extended the PDUFA program for five more years (PDUFA III). Information about PDUFA III, including the text of the amendments and the performance goals and procedures, can be found at www.fda.gov/oc/pdufa/default.htm.
PDUFA requires FDA to submit two annual reports to the President and the Congress for each fiscal year during which fees are collected: 1) a performance report due within 60 days of the end of the fiscal year, and 2) a financial report due within 120 days of the end of the fiscal year. This document fulfills the first of these requirements for FY 2004. This year's report covers FDA's progress in meeting the quantifiable PDUFA review goals for FYs 2003 and 2004 submissions and the FY 2004 processing and procedural goals. The report also describes FDA's progress in accomplishing new management initiatives and in meeting the information technology commitments of PDUFA III.