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  1. FDA User Fee Programs

Prescription Drug User Fee Amendments

Latest News:

  • The FY 2023 Clean-Up Program Fee invoices were emailed on Friday, December 15, 2023.  Full payment of the clean-up invoice is due on January 16, 2024.  If you do not receive your invoice by Monday December 18, 2023, but believe you should have, please contact the PDUFA User Fee staff at CDERCollections@fda.hhs.gov.
  • FDA has updated the address for user fees delivered by courier, such as Federal Express or UPS.  Beginning October 6th, to prevent any disruption of overnight packages, please send any payment arriving via courier to:

    U.S. Bank
    Attention: Government Lockbox 979107
    3180 Rider Trail South
    Earth City, MO 63045 

    If you have any questions concerning courier delivery, contact U.S. Bank at 800-495-4981.

  • On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022, which includes the reauthorization of the Prescription Drug User Fee Act (PDUFA VII) from fiscal year (FY) 2023 through 2027. Additional information can be found on the PDUFA VII web page.

FY 2023 and FY 2024 User Fee Rates

Fee Category Fee Rates for FY 2023 Fee Rates for FY 2024
Application    
     Requiring clinical data $3,242,026 $4,048,695
     Not requiring clinical data $1,621,013 $2,024,348
Program $393,933 $416,734

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect user fees from persons that submit certain human drug applications for review or that are named in approved applications as the sponsor of certain prescription drug products. Since the passage of PDUFA, user fees have played an important role in expediting the drug review and approval process.

PDUFA must be reauthorized every five years, and was renewed in 1997 (PDUFA II), 2002 (PDUFA III), 2007 (PDUFA IV), and 2012 (PDUFA V), 2017 (PDUFA VI), and 2022 (PDUFA VII). On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022, which includes the reauthorization of PDUFA through September 2027. PDUFA VII will provide for the continued timely review of new drug and biologic license applications.

 



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