PDUFA Reports and Other Documents

Reports

Performance

• Prescription Drug User Fee Act (PDUFA) FY 2006 Performance Report to Congress [HTML] or [PDF]
  
  
• Prescription Drug User Fee Act (PDUFA) FY 2005 Performance Report to Congress [HTML] or [PDF]
   
• Prescription Drug User Fee Act (PDUFA) FY 2004 Performance Report to Congress [HTML] or [PDF]
   
• Prescription Drug User Fee Act (PDUFA) FY 2003 Performance Report to Congress 
   
• Prescription Drug User Fee Act (PDUFA) FY 2002 Performance Report to Congress
  
  
• Prescription Drug User Fee Act (PDUFA) FY 2001 Performance Report to Congress
  
  
• Prescription Drug User Fee Act (PDUFA) FY 2000 Performance Report to Congress
  
  
• Prescription Drug User Fee Act (PDUFA) FY 1999 Performance Report to Congress [HTML] or [PDF]
  
  
• Prescription Drug User Fee Act (PDUFA) FY 1998 Performance Report to Congress [HTML] or [PDF]
  
  
• Prescription Drug User Fee Act (PDUFA) FY 1997 Performance Report to Congress (HTML)
  
  
• Prescription Drug User Fee Act (PDUFA) FY 1996 Performance Report to Congress (HTML)
  
  
• Prescription Drug User Fee Act (PDUFA) FY 1995 Performance Report to Congress (HTML)
  
  

Financial

• Prescription Drug User Fee Act (PDUFA) FY 2006 Financial Report to Congress [HTML] or [PDF]
  
  
• Prescription Drug User Fee Act (PDUFA) FY 2005 Financial Report to Congress [HTML] or [PDF]
  
  
• Prescription Drug User Fee Act (PDUFA) FY 2004 Financial Report to Congress [HTML] or [PDF]
  
  
• Prescription Drug User Fee Act (PDUFA) FY 2003 Financial Report to Congress [HTML] or [PDF]
  
  
• Prescription Drug User Fee Act (PDUFA) FY 2002 Financial Report to Congress [HTML] or [PDF]
  
  
• Prescription Drug User Fee Act (PDUFA) FY 2001 Financial Report to Congress
  
  
• Prescription Drug User Fee Act (PDUFA) FY 2000 Financial Report to Congress
  
  
• Prescription Drug User Fee Act (PDUFA) FY 1999 Financial Report to Congress
  
  
• Prescription Drug User Fee Act (PDUFA) FY 1998 Financial Report to Congress [HTML]  [PDF]
  
  
• Prescription Drug User Fee Act (PDUFA) FY 1997 Financial Report to Congress
  
  
• Prescription Drug User Fee Act (PDUFA) FY 1995 Financial Report to Congress

Other Documents and Links

• Independent Evaluation of FDA's First Cycle Review Performance – Final Report [HTML] or [PDF] (7/16/2008)
  
  
• Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (Draft) (4/1/2008)
  
  
• Prescription Drug User Fee Act (PDUFA) CDER Billable Biologic Products (3/31/2008)
  
  
• PDUFA IV White Paper -  Prescription Drug User Fee Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug Applications [HTML] or [PDF] or [Word] (11/22/2005)
  
  
• Important notice - pediatric supplements no longer exempt from fees (1/8/2002)
  
  
• Payment Instructions for Applications and Supplements (updated 3/15/2004)
  
  
• PDUFA 3 Five Year Plan (10/2003)
  
  
• User Fee Cover Sheet
  
  
• Electronic Regulatory Submission and Review (ERSR) Program--PDUFA II Information Management Advisory Board
  
  
• Electronic Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)

Back to Top     Back to PDUFA

PDF requires the free Adobe Acrobat Reader

Date created: January 31, 2007, updated July 30, 2008

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research