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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:

  • 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21 U.S.C. § 379j–42 (b)(2)(E)(ii), ANDA withdrawal requests submitted by April 1, 2020 will be deemed to have been withdrawn for purposes of program fee size determinations for FY 2021.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).
  • The Generic Drug User Fees for Fiscal Year 2019 have been published. Please see the table below for the GDUFA II user fee rates. 
  • 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 2018 FY 2019 FY 2020
ANDA $ 171,823 $ 178,799 $ 176,237
DMF $ 47,829 $ 55,013 $57,795
Program Large Size $ 1,590,792 $ 1,862,167 $ 1,661,684
Medium Size $ 636,317 $ 744,867 $ 664,674
Small Size $ 159,079 $ 186,217 $ 166,168
Facility Domestic API $ 45,367 $ 44,226 $ 44,400
Foreign API $ 60,367 $ 59,226 $ 59,400
Domestic FDF $ 211,087 $ 211,305 $ 195,662
Foreign FDF $ 226,087 $ 226,305 $ 210,662
Domestic CMO $ 70,362 $ 70,435 $ 65,221
Foreign CMO $ 85,362 $ 85,435 $ 80,221
Backlog $ 17,434 $ 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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