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  1. FDA User Fee Programs

Generic Drug User Fee Amendments

On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022, which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2027 (GDUFA III). Congress first enacted GDUFA in 2012, following negotiations between the FDA and industry and with input from public stakeholders. Congress enacted GDUFA to ensure patients have access to safe, high-quality, and affordable generic drugs. GDUFA enables FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic drug applications.

This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information. Additional information can be found on the GDUFA III Reauthorization web page.

Latest News

  • 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 979108
    3180 Rider Trail South
    Earth City, MO 63045

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

  • FY 2024 cover sheets are now available in the User Fee System.
  • The fiscal year (FY) 2024 GDUFA fee rates were published in the Federal Register on July 28, 2023. For more information regarding the FY 2024 fee rates, please see the FR notice available here.
  • FDA reports GDUFA III activities and metrics—including approvals, submissions, meetings, DMF fees, and other actions—on a monthly basis.
  • Points of Contact for Questions Related to Generic Drugs provides information and assistance on topics related to the Generic Drugs Program and GDUFA.
  • As FDA publishes and updates guidances, CDER’s Manual of Policies and Procedures, and other deliverables to fulfill GDUFA III commitments, these items are added to the appropriate pages linked on the left.

FY 2023 and FY 2024 User Fee Rates

User Fee Type


FY 2023

FY 2024



$ 240,582

$ 252,453



$ 78,293

$ 94,682


Large Size

$ 1,620,556

$ 1,729,629


Medium Size

$ 648,222

$ 691,852


Small Size

$ 162,056

$ 172,963


Domestic API

$ 37,544

$ 40,464


Foreign API

$ 52,544

$ 55,464


Domestic FDF

$ 213,134

$ 220,427


Foreign FDF

$ 228,134

$ 235,427


Domestic CMO

$ 51,152

$ 52,902


Foreign CMO

$ 66,152

$ 67,902



$ 17,434

$ 17,434

*The one-time backlog fee was set in FY 2013 only. Those who have not paid for the incurred backlog fee may email CDERCollections@fda.hhs.gov for further assistance.

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