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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-2/
- Published: 2017-07-25T12:00:00.000Z
- Updated: 2026-09-14T22:36:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139212

FDA has posted a [guidance](https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM530476.pdf?ref=fdaweb.com) on “Generic Drug User Fee Amendments of 2012 — Questions and Answers” that gives FDA’s position on such issues as self-identification, generic drug submission reviews, and inspections and compliance. Questions and answers related to user fee assessments can be found in a separate guidance on “Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments (11/2016).”