Letters (PDUFA)

• 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)