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  1. FDA User Fee Programs

Generic Drug User Fee Amendments

On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2022. 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. More information about GDUFA II is available on the Generic Drug User Fee Amendments Implementation Activities page.

Latest News:

  • The GDUFA user fee rates for Fiscal Year (FY) 2021 was published in the Federal Register.  Please see the table below for the FY 2020 and FY 2021 rates.
  • The FDA is announcing a virtual public meeting to discuss stakeholder recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2023 through 2027. The virtual public meeting will be held on July 21, 2020, from 9 a.m. to 3 p.m., and will be held by webcast only. Please visit the meeting web page for more information.
  • In preparation for the Fiscal Year (FY) 2021 GDUFA Generic Drug Applicant Program Fee, please confirm your affiliates and the approved ANDAs owned by you and your affiliates via the FDA CDER Direct NextGen Collaboration Portal.  Note that, in accordance with the Federal Food, Drug, and Cosmetic Act (FDCA) § 744B, 21 U.S.C. § 379j–42 (b)(2)(E)(ii), ANDA withdrawal requests submitted by April 1, 2020 will be deemed to have been withdrawn for purposes of program fee size determinations for FY 2021. To ensure the Agency has enough time to process Transfers of Ownership, FDA encourages Applicants to submit this information by April 1st as well. Please note, all Withdrawal requests and Transfers of Ownership must be sent to the official record of the ANDA via the Electronic Submissions Gateway (ESG).
  • NEW! Visit Points of Contact for Questions Related to Generic Drugs for information on topics related to the Generic Drugs Program and GDUFA.
  • The GDUFA publicly available Arrears Lists for FY 2020 are available. To review our lists, please click here.

GDUFA II User Fee Rates

User Fee Type FY 2020 FY 2021
ANDA $ 176,237 $ 196,868
DMF $ 57,795 $ 69,921
Program Large Size $ 1,661,684 $ 1,542,993
Medium Size $ 664,674 $ 617,197
Small Size $ 166,168 $ 154,299
Facility Domestic API $ 44,400 $ 41,671
Foreign API $ 59,400 $ 56,671
Domestic FDF $ 195,662 $ 184,022
Foreign FDF $ 210,662 $ 199,022
Domestic CMO $ 65,221 $ 61,341
Foreign CMO $ 80,221 $ 76,341
Backlog $ 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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