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GUIDANCE DOCUMENT

FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary April 2019

Final

FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary

Docket Number:
FDA-2016-D-2730
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to clarify how the Food and Drug Administration (FDA or Agency) applies the factors set forth in section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. This guidance fulfills one of the performance goals that FDA agreed to satisfy in the reauthorization of the Prescription Drug User Fee Act (PDUFA) V.


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All written comments should be identified with this document's docket number: FDA-2016-D-2730.