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# IR, DRL Guidance
- URL: https://www.fdaweb.com/ir-drl-guidance/
- Published: 2022-10-05T12:00:00.000Z
- Updated: 2026-09-14T18:02:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152895

FDA has published a guidance, *Information Requests and Discipline Review Letters*, explaining how the agency will issue and use an information request (IR) and/or a discipline review letter (DRL) during the assessment of an original section 505(j) ANDA. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-requests-and-discipline-review-letters-under-generic-drug-user-fee-amendments?ref=fdaweb.com) does not apply to a supplement or an amendment to a supplement.

The guidance revises one issued 1/2022 to incorporate information on IRs and DRLs from the GDUFA 3 reauthorization.