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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

  • FY 2023 GDUFA user fees are provided in the table below. FY 2023 cover sheets are available in the User Fee System.
  • 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 2022 and FY 2023 User Fee Rates

User Fee Type


FY 2022

FY 2023



$ 225,712

$ 240,582



$ 74,952

$ 78,293


Large Size

$ 1,536,856

$ 1,620,556


Medium Size

$ 614,742

$ 648,222


Small Size

$ 153,686

$ 162,056


Domestic API

$ 42,557

$ 37,544


Foreign API

$ 57,557

$ 52,544


Domestic FDF

$ 195,012

$ 213,134


Foreign FDF

$ 210,012

$ 228,134


Domestic CMO

$ 65,004

$ 51,152


Foreign CMO

$ 80,004

$ 66,152



$ 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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