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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