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# ANDA Letters Guidance
- URL: https://www.fdaweb.com/anda-letters-guidance/
- Published: 2018-01-02T12:00:00.000Z
- Updated: 2026-09-14T23:09:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140380

FDA has published a draft guidance, *Information Requests and Discipline Review Letters under GDUFA*, explaining how the agency will issue and use an information request (IR) and/or a discipline review letter (DRL) during review of an ANDA as contemplated in GDUFA 2\. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588862.pdf?ref=fdaweb.com) says the guidance does not apply to an amendment made in response to a complete response letter, a supplement, or an amendment to a supplement.

Under GDUFA 1, FDA says, the agency committed to performance goals for acting on received ANDAs. It now is committed to provide applicants preliminary thoughts on possible deficiencies as each review discipline finishes its initial review of its portion of a received application, except when the review results in the ability to act on an application.

During the GDUFA 2 negotiations, the document says, it was agreed that FDA will **(1)** issue an IR to request further information or clarification that is needed or would be helpful to allow completion of a discipline review, and/or **(2)** issue a DRL, a new type of letter for ANDAs, to convey preliminary thoughts on possible deficiencies found by a discipline reviewer and/or review team for its or their portion of the application under review at the conclusion of a discipline review.

At about the mid-point of the review clock, the guidance says, FDA will send either an IR or a DRL to the applicant, except when a discipline review results in the ability to act on a received ANDA.