Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Development of a Shared System REMS.'' This draft guidance provides recommendations on the development of a shared system risk evaluation and mitigation strategy (REMS) for multiple prescription drug (including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.