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GUIDANCE DOCUMENT

Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments Guidance for Industry January 2022

Download the Final Guidance Document
Final Level 1 Guidance
Docket Number:
FDA-2017-D-6752
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance explains how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the assessment of an original abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)), as contemplated in the Generic Drug User Fee Amendments of 2017 (GDUFA II). This guidance does not apply to an amendment made in response to a complete response letter (CRL), a supplement, or an amendment to a supplement.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-6752.

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