This guidance provides recommendations to industry on the development of a shared system risk evaluation and mitigation strategy (REMS) for multiple prescription drug (including biological) products.This guidance describes some of the possible benefits of a shared system REMS, and provides general principles and recommendations to assist industry with the development of these programs. This guidance does not discuss the process for requesting a waiver of the single, shared system REMS requirement that applies to abbreviated new drug applications (ANDAs) referencing a listed drug with an approved REMS. FDA issued a separate guidance describing the process for requesting waivers and the criteria FDA applies in considering them.

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Development of a Shared System REMS .Guidance for Industry