PDUFA Performance Reports

PDUFA was authorized in FY 1993 for five years. PDUFA has been re-authorized for five additional years three times and is currently authorized through FY 2012. Annual performance reports are prepared by FDA’s Office of Policy and Planning in collaboration with the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research.

 

• PDUFA I (FY 1993 through FY 1997) *   
• PDUFA II (FY 1998 through FY 2002)
• PDUFA III (FY 2003 through FY 2007)
• PDUFA IV (FY 2008 through 2012)   

 

*FY 1993 and FY 1994 reports can be obtained through the contact information provided below.

                    

For additional information on these reports, please contact:

 

Office of Policy and Planning

Food and Drug Administration

10903 New Hampshire Avenue

Building 1, Room 4300

Silver Spring, Maryland 20993-0002

Phone: 301-796-4850

FAX: 301-847-3541