U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Generic Drug User Fee Amendments
  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 cover sheets are now available in the User Fee System.
  • On October 12, 2022, the Food and Drug Administration announced the Generic Drug User Fee Rates for Fiscal Year 2023 in the Federal Register for fees assessed under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These fees apply to the period from October 1, 2022, through September 30, 2023 (fiscal year 2023). Under section 744B(a)(5) of the FD&C Act, the program fee and facility fee are generally due on the later of (1) the first business day on or after October 1 of each fiscal year; or (2) the first business day after the enactment of an appropriations Act providing for the collection and obligation of GDUFA fees for the fiscal year. For fiscal year 2023, that date would be October 3, 2022. However, given the September 30, 2022 date of the GDUFA reauthorization for fiscal years 2023 through 2027, the program fee and facility fee for FY 2023 should be paid within 30 days from the issue date of the Federal Register notice (i.e., 30 days from October 12, 2022).
  • As part of the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal years 2023-2027, starting in fiscal year 2023, FDA will publish the number of DMF fees paid in the reporting month on its website. The report will be updated and available on the 5th of each month with the total monthly count of DMF payments received during the previous month. The GDUFA Type II API DMF Payment Receipts report is available under the User Fee Lists section below.
  • 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.
  • IMPORTANT NOTICE REGARDING GENERIC DRUG USER FEE STAFF CONTACT INFORMATION: Due to the COVID-19 pandemic, and until further notice, electronic mail is the Generic Drug User Fee staff’s preferred method of receiving communication over postal mail.  If you have questions or documentation for the Generic Drug User Fee staff regarding GDUFA Fee requirements, please send them by electronic mail to CDERCollections@fda.hhs.gov.  Please continue to contact the User Fee Helpdesk at userfees@fda.gov for technical assistance with the User Fee System or GDUFA Cover Sheet and pay.gov.clev@clev.frb.org for questions about Pay.gov
  • NEW! Visit Points of Contact for Questions Related to Generic Drugs for information on topics related to the Generic Drugs Program and GDUFA.

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.

Back to Top