Prescription Drug User Fee Act (PDUFA) > Letters (PDUFA)

Prescription Drug User Fee Act (PDUFA) > Letters (PDUFA)

Letters (PDUFA)

  

• The Prescription Drug Uer Fee Act (PDUFA) Dear Colleague Letter (PDF - 413KB), 5/4/2012
  Attachment A (PDF - 16KB)   Attachment B (PDF - 17KB) (Posted 5/30/2012) 
• Proposed PDUFA V Statutory Language (PDF - KB)
• Proposed PDUFA V Reauthorization Performance Goals and Procedures; Fiscal Years 2013 through 2017 (PDF - 352KB) (Posted 9/1/2011)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 371KB), 5/5/2011
  Attachment A (PDF - 16KB)   Attachment B (PDF - 17KB) (Posted 5/6/2011)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 449KB), 5/5/2010
  Attachment A (PDF - 14KB)   Attachment B (PDF - 15KB) (Posted 5/6/2010)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 2MB), 5/5/2009
  Attachment A (PDF - 9KB)   Attachment B (PDF - 10KB) (Posted 5/8/2009)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 601KB),  5/5/2008
  Attachment B (PDF - 17KB) (Posted 5/6/2008)
• PDUFA IV Transmittal Letter to Congress, 9/27/2007 or (PDF - 41KB)
• PDUFA IV Reathorization Performance Goals and Procedures; Fiscal Years 2008 through 2012
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter, 5/4/2007 (PDF - 218KB)
  PDF Attachments: Attachment B (PDF - 33KB) (Posted 5/4/2007)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter, 5/5/2006 (PDF - 2MB)
  PDF Attachments: Attachment B (PDF - 170KB) (Posted 5/8/2006)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter, 5/5/2005 or (PDF - 170KB)
  PDF Attachments: Attachment B (PDF - 21KB) (Posted 5/6/2004)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter, 5/5/2004 or (PDF - 321KB)
  PDF Attachments: Attachment B (PDF - 22KB) (Posted 5/13/2004)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter, 5/5/2003 or (PDF - 201KB) (Posted 5/9/2003)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague letter, 6/12/2002 or (PDF - 579KB) (Posted 5/9/2003)
• Text of the June 4, 2002, letter transmitting the PDUFA III performance goals and procedures (10/2003)
• PDUFA III Reauthorization Performance Goals and Procedures (Enclosure from 6/4/2002 letter) (10/2003)
• The Prescription Drug User Fee Act (PDUFA) User Fee Correspondence, 10/1/97 (PDF - 9KB)
• 11/12/97 Sec. Shalala letter to Sen. Jeffords regarding the goals pertaining to the reauthorization of the Prescription Drug User Fee Act
• PDUFA Reauthorization Performance Goals and Procedures (Enclosure from 11/12/1997 Sec. Shalala letter to Sen. Jeffords)