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  1. FDA User Fee Programs

Prescription Drug User Fee Amendments

Latest News:

  • In preparation for FDA’s FY 2024 PDUFA program fee invoices, the Dear Colleague Letter (DCL) was emailed on Friday, May 5, 2023. Please submit your response to CDERCollections@fda.hhs.gov by Thursday, June 1, 2023. If you have any questions regarding the DCL, please send an email to the Dear Colleague Letter Coordinator at CDERCollections@fda.hhs.gov.
  • FDA announces the publication of the final guidance for industry entitled Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022.  This final guidance concerns FDA's implementation of the Prescription Drug User Fee Amendments of 2022 and changes created by the statute to definitions, to certain user fee exceptions, and to user fee policies and procedures.
  • Beginning February 13, 2023, CDER and CBER will begin accepting meeting requests for in-person, face-to-face industry meetings (with a hybrid component), starting with Type A, BPD Type 1, and Type X meeting requests.
  • CDER’s Work to Meet User Fee Goals During the Pandemic: This webpage will provide periodic updates on key user fee metrics related to application review and the pre-approval process throughout the COVID-19 pandemic.

FY 2022 and FY 2023 User Fee Rates

User Fee Type 2022 2023
Application Fee – Clinical Data Required $3,117,218 $3,242,026
Application Fee – No Clinical Data Required $1,558,609 $1,621,013
Program Fee $369,413 $393,933

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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