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USFDA Guidance: Assessing User Fees Under the GDUFA of 2022

Today (09 June 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated final guidance on "Assessing User Fees Under the Generic Drug User Fee Amendments of 2022".

Generic Drug User Fee Amendments (GDUFA) is a program implemented by the USFDA to expedite the review and approval of generic drugs while ensuring safety and quality standards are met through user fees paid by generic drug manufacturers.

In this guidance, FDA provides information on the types of user fees authorized under GDUFA III, how to submit payments to the FDA, the consequences for failing to pay generic drug user fees, as well as how to request a reconsideration of a user fee assessment previously developed under earlier GDUFA authorizations.

The guidance also describes how FDA determines affiliation for purposes of assessing generic drug user fees, and FDA will issue separate guidance documents regarding non-user fee requirements and processes under GDUFA III.

The GDUFA program fee will be allocated among three tiers of ANDA owners:

  1. Small (companies with 5 or fewer approved ANDAs)

  2. Medium (companies with 6 to 19 approved ANDAs)

  3. Large (companies with 20 or more approved ANDAs)

The amount of fee for a facility located outside the United States, and its territories and possessions, is $15,000 higher than the amount of the fee for a domestic facility.

Non-payment or incomplete payment of user fees under GDUFA may lead to penalties imposed on an organization and its related entities, depending on the specific fee type.


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