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# GDUFA 2 User Fee Assessment
- URL: https://www.fdaweb.com/gdufa-2-user-fee-assessment/
- Published: 2019-10-31T12:00:00.000Z
- Updated: 2026-09-14T15:51:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145387

FDA has issued a draft guidance, *Assessing User Fees Under the Generic Drug User Fee Amendments of 2017*, to give stakeholders information on the agency’s implementation of GDUFA 2\. “Because GDUFA 2 created changes to the user fee program,” the [document](https://www.fda.gov/media/132138/download?ref=fdaweb.com) says, “this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.”

The guidance describes the types of user fees authorized by GDUFA 2, the process 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. It also describes how the agency determines affiliation for purposes of assessing generic drug user fees.

The agency says it will issue separate guidances about GDFUA 2 non-user fee requirements and processes. This guidance does not address how FDA determines and adjusts fees each fiscal year, and it does not address the implementation of other user fee programs.