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.
A REMS is a required risk management strategy that employs tools beyond prescribing information to ensure that the benefits of a drug outweigh its risks.
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.
FDA can require a REMS before initial approval of a new drug application (NDA). A shared system for REMS with elements to assure safe use (ETASU) may offer benefits to drug applicants and stakeholders in the health care delivery system. A shared system REMS encompasses multiple prescription drug products and is developed and implemented jointly by two or more applicants. A REMS that includes more than one product but only a single applicant is not considered a shared system REMS.
A shared system REMS uses a single REMS document, supporting document, and REMS materials, agreed to by all applicants and approved as part of each application.
A shared system REMS generally uses a shared infrastructure for all of the products in the REMS. This generally provides a single portal for REMS participants to engage in and undertake the activities of the program. A shared infrastructure 95 can also allow for a single set of REMS materials and information about the program.
