GUIDANCE DOCUMENT
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry Draft Guidance for Industry December 2017
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2017-D-6752
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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 review 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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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All written comments should be identified with this document's docket number: FDA-2017-D-6752.