Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments

On 26 January 2022 the FDA issued the final guidance for industry.

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.

Under the Generic Drug User Fee Amendments of 2012 (GDUFA I), FDA committed to performance goals for acting on received ANDAs. FDA also committed to performance goals for acting on received ANDAs under GDUFA II. In addition to these performance goals, FDA is now committed to provide applicants preliminary thoughts on possible deficiencies as each assessment discipline finishes its initial assessment of its portion of the received application (except when that assessment results in the ability to act on such application).

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