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# FDA Guide on Generic User Fee Questions & Answers
- URL: https://www.fdaweb.com/fda-guide-on-generic-user-fee-questions-answers/
- Published: 2016-11-17T12:00:00.000Z
- Updated: 2026-09-14T21:48:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137379

FDA has released a [guidance](https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-27761.pdf?ref=fdaweb.com) on “Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments,” a revision that answers common questions from the generic drug industry and other interested parties on GDUFA user fees. The document updates and clarifies the responses in some cases and adds questions and answers based on comments received from the public. Also, FDA says questions and answers related to GDUFA's self-identification, review of generic drug submissions, and inspections and compliance provisions that appeared in draft versions of the guidance will appear in updated form in a separately issued final guidance.