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# Assessing GDUFA User Fees Guidance
- URL: https://www.fdaweb.com/assessing-gdufa-user-fees-guidance/
- Published: 2023-06-08T12:00:00.000Z
- Updated: 2026-09-14T18:37:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154649

FDA has published a guidance, *Assessing User Fees Under the Generic Drug User Fee Amendments of 2022*, with an explanation of the new fee structure and types of fees for which entities are responsible under changes made in the GDUFA 3 reauthorization in 2022\. The [document](https://www.fda.gov/media/132138/download?ref=fdaweb.com) describes the types of user fees authorized by GDUFA 3 and the processes for submitting payments to FDA, the consequences for failing to pay generic drug user fees, and the process for requesting a reconsideration of a user fee assessment previously developed under earlier GDUFA authorizations.

It also describes how FDA determines affiliation for purposes of assessing generic drug user fees.