Letters (PDUFA)

• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 255 KB), (Posted 5/5/2025)
  Attachment A (PDF - 797KB) | Attachment B (PDF - 195KB) (Posted 5/5/2025)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 232 KB), (Posted 5/3/2024)
  Attachment A (PDF - 789KB) | Attachment B (PDF - 155KB) (Posted 5/3/2024)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 313 KB), (Posted 5/5/2023)
  Attachment A (PDF - 772KB) | Attachment B (PDF - 140KB) (Posted 5/5/2023)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 297KB), 5/2/2022
  Attachment A (PDF - 772KB) | Attachment B (PDF - 695KB) (Posted 5/2/2022)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 215KB), 5/3/2021
  Attachment A (PDF - 742KB) | Attachment B (PDF - 695KB) (Posted 5/3/2021)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 144KB), 5/4/2020
  Attachment A (PDF - 742KB) | Attachment B (PDF - 695KB) (Posted 5/4/2020)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF -  175KB), 5/6/2019
  Attachment A (PDF - 732KB) | Attachment B (PDF - 689KB) (Posted 5/6/2019)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 376 KB), 5/14/2018
  Attachment A (PDF - 731 KB) | Attachment B (PDF - 137 KB) (Posted 5/14/2018)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 153KB), 7/31/2017
  Attachment A (PDF - 581KB) | Attachment B (PDF - 119KB) (Posted 7/31/2017)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 51KB), 5/5/2016
  Attachment A (PDF - 582KB) | Attachment B (PDF - 146KB) (Posted 5/5/2016)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 1MB), 5/5/2015
  Attachment A (PDF - 8KB) | Attachment B (PDF - 10KB) (Posted 5/7/2015)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 403KB), 5/5/2014
  Attachment A (PDF - 22KB) | Attachment B (PDF - 26KB) (Posted 5/5/2014)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter (PDF - 54KB), 5/3/2013
  Attachment A (PDF - 14KB) | Attachment B (PDF - 15KB) (Posted 5/3/2013)
• The Prescription Drug User 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 - 69KB)
• 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)

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• 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)

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• 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)

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