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

5 October 2022 — FDA published final guidance on IRs and discipline review letters under GDUFA.

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 GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter).

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