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# PDUFA 6 User Fee Guidance Out
- URL: https://www.fdaweb.com/pdufa-6-user-fee-guidance-out/
- Published: 2018-05-02T12:00:00.000Z
- Updated: 2026-09-15T00:02:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141345

FDA has issued a guidance, *Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017*, describing the types of user fees authorized by PDUFA 6, the process for submitting payments to FDA, the consequences for failing to pay application fees or prescription drug program fees, and the process for requesting a reconsideration of a user fee assessment. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM580099.pdf?ref=fdaweb.com) also describes how the agency determines which products are subject to a fee and discusses certain changes to FDA policies under the new law.

The agency says there are separate guidances about PDUFA 6 waivers, refunds, and reductions. The guidance does not address how FDA determines and adjusts fees each fiscal year and does not consider implementation of other user fee programs.

Guidance contents include an introduction and background statement, definitions, changes to the PDUFA user fee program structure, human drug application fees, prescription drug program fees, waivers of PDUFA fees, effect of failure to pay fees, payment information and procedures, fee waiver reduction or refund requests and appeals process, and other resources.