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# Guide on PDUFA Implementation
- URL: https://www.fdaweb.com/guide-on-pdufa-implementation/
- Published: 2018-05-03T12:00:00.000Z
- Updated: 2026-09-15T00:02:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141362

*Federal Register* notice: FDA has made available a final guidance entitled “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.” The document addresses FDA’s implementation of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and certain changes in policies and procedures surrounding its application. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-05-03/pdf/2018-09366.pdf?ref=fdaweb.com).