About FDA
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PDUFA Performance Reports
PDUFA was authorized in FY 1993 for five years. PDUFA has been reauthorized for five additional years three times and is currently authorized through FY 2012. Annual performance reports are prepared by FDA’s Office of 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 Planning
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002
Phone: 301-796-4850
FAX: 301-847-3541
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PDUFA Performance Reports
FY 2011 PDUFA Performance Report FY 2010 PDUFA Performance Report FY 2009 PDUFA Performance Report FY 2008 PDUFA Performance Report FY 2007 PDUFA Performance Report FY 2006 PDUFA Performance Report FY 2005 PDUFA Performance Report FY 2004 PDUFA Performance Report FY 2003 PDUFA Performance Report FY 2002 PDUFA Performance Report FY 2001 PDUFA Performance Report FY 2000 PDUFA Performance Report FY 1999 PDUFA Performance Report FY 1998 PDUFA Performance Report FY 1997 PDUFA Performance Report FY 1996 PDUFA Performance Report FY 1995 PDUFA Performance Report
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