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The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.
FDA published the final version of its REMS guidance document, Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry, on July 9, 2019. The guidance provides information on types of approved risk evaluation and mitigation strategies (REMS) and how applicants should submit changes to an approved REMS. The guidance also clarifies the differences between modifications of a REMS and revisions of a REMS.
FDA timeframes for assessing REMS changes-including revisions, minor modifications, major modifications, modifications due to safety labeling changes, and multiple types of REMS changes-are also included in the document. An appendix provides detailed submission procedures.
The guidance applies to all types of REMS but does not address additional submission procedures that may apply to application holders proposing changes to a shared system and that use a drug master file for their REMS submission.