Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures

The U.S. Food and Drug Administration (FDA) recently posted a manual of policies and procedures (MAPP) that describes the policy, responsibilities, and procedures to be used in the FDA Center for Drug Evaluation and Research (CDER) for: Developing a single, shared system (SSS) risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) for a reference listed drug (RLD) and abbreviated new drug application(s) (ANDA(s)) that reference the RLD during the review of the ANDA(s), and Developing a separate REMS with ETASU (if applicable) for an ANDA during the review of the ANDA. MAPPs are federal directives and documentation of internal policies and procedures, which fulfill FDA’s obligation to maintain adequate systems of internal control for accounting and administrative activities. They are available to the public to make CDER a more transparent organization.  A REMS is a required risk management plan that uses tools beyond the approved labeling (prescribing information) to manage risks associated with a drug. Under section 505-1 of the Federal Food, Drug, and Cosmetic Act, the FDA has the authority to require a manufacturer to develop a REMS when the FDA determines it necessary to ensure that the benefits of a drug outweigh its risks. Single, shared system REMS include ETASU and at least one generic drug product, as well as its reference listed drug (sometimes referred to as the brand name product).  Single, shared REMS systems can be complex and challenging to establish and run. In June 2018, FDA issued two guidances designed to help industry navigate these challenges: Development of a Shared System REMS and Waivers of the Single, Shared System REMS Requirement. The latter guidance provides clarity to help alleviate the delays in ANDA approvals that can be caused by prolonged negotiations over the development of a single, shared system REMS. Following the release of these guidances, CDER determined that a MAPP would be useful for staff, and other interested parties, responsible for reviewing or developing certain types of REMS.   FDA is committed to making our review processes as transparent as possible, and MAPPs help us meet this goal by providing clear operating procedures, in writing, for both staff and applicants.  If you have questions about this MAPP or the development of a single, shared system REMS or separate REMS with ETASU, please email druginfo@fda.hhs.gov or submit a Contact REMS Form on the FDA website.