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In this section: Prescription Drug User Fee Amendments

Letters (PDUFA)

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)

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)

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)

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