FDA Issues Manual on Developing a Shared System REMS

The FDA released a new manual of policies and procedures (MAPP) for agency staff on developing a shared system risk evaluation and mitigation strategy (REMS).

The MAPP builds on June 2018 guidance on developing shared system REMS and waivers of the shared REMS requirement.

The manual outlines procedures for developing a single, shared system REMS with elements to assure safe use (ETASU) for a reference listed drug (RLD) and abbreviated new drug application that references the reference drug during the ANDA review. In such situations, the FDA’s Office of Generic Drugs will issue a REMS notification letter to the ANDA applicant informing them of the requirement to establish a shared REMS with the sponsor of the referenced NDA.