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In this section: Prescription Drug User Fee Amendments

PDUFA User Fee Rates Archive

Federal Register Notices that Establish User Fee Rates

Establishment of Prescription Drug User Fee Rates for Fiscal Year 2025 (Posted 7/31/2024)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2024 (Posted 8/2/2023)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2023 (Posted 10/7/2022)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2022 (Posted 8/16/2021)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2021 (Posted 8/3/2020)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2020 (Posted 8/2/2019)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2019 (Posted 8/1/2018)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2018 (Posted 9/15/2017)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2017 (Posted 8/9/2016)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2016 (Posted 9/14/2015)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2015 (Posted 8/4/2014)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2014 (Posted 8/1/2013)
Correction Notice: Prescription Drug User Fee Rates for Fiscal Year 2014 (Posted 8/28/2013)
- Notice to applicants who owe PDUFA establishment or product fees for FY 2014:
  In accordance with PDUFA, 21 U.S.C. § 379h(a)(2)(A) and (a)(3)(A), prescription drug establishment and product fees for FY 2014 are due “on...the first business day after the enactment of an appropriations Act providing for the collection and obligation of [PDUFA] fees for fiscal year [2014].” Because the Continuing Resolution (an appropriations Act) for fiscal year 2014 was enacted on October 17, 2013, prescription drug establishment and product fees assessed for fiscal year 2014 are due on October 18, 2013.
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2013 (PDF - 214KB) (Posted 8/1/2012)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2012 (PDF - 218KB) (Posted 7/29/2011)
Fee for Using a Priority Review Voucher in Fiscal Year 2011 (PDF - 51KB) (Posted 9/13/2010)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2011 (PDF - 64KB) Posted 8/4/2010)
- New payment instructions for application and supplement fees, effective 2/24/2011 (Posted 2/24/2011)
Prescription Drug User Fee Rates for Fiscal Year 2010; Correction (PDF - 58KB) (Posted 11/13/2009)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2010 or (PDF - 61.6 KB) (Posted 8/3/2009)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2009 or (PDF - 73KB) (Posted 8/1/2008)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2008 or (PDF - 59KB) (Posted 10/15/2007)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2007 or (PDF - 99KB) (Posted 8/2/2006)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2006 or (PDF - 62KB) (Posted 8/1/2005)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2005 or (PDF - 58KB) (Posted 7/30/2004)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2004 or (PDF - 47KB) (Posted 8/1/2003)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2003 or (PDF - 47KB) (Posted 8/2/2002)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2002 or (PDF - 111KB) (Posted 1/14/2002)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2001. Pages 79107-79111 [FR Doc. 00-31949] or (PDF - 154KB) (12/18/2000)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2000 (64 FR 72699, December 28, 1999) or (PDF - 147KB)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 1999 (63 FR 70777, December 22, 1998) (PDF - 53KB)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 1998 (62 FR 64849, December, 9, 1997) (PDF - 25KB)
Establishment of Prescription Drug User Fee Rates for Fiscal Year 1998, Correction (62 FR 67878, December 30, 1997) (PDF - 14KB)

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