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FDA Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary



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

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