MAPP on REMS Development

CDER has issued a Manual on Policies and Procedures (MAPP), Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use: Responsibilities and Procedures, outlining policy, responsibilities, and procedures to be used in CDER for two types of REMS — a SSS REMS with elements to assure safe use (ETASU) for a reference-listed drug (RLD) and ANDAs that reference the RLD during the review of the ANDA, and a separate REMS that uses a different, comparable aspect of the RLD ETASU for an ANDA during its review. “This MAPP covers the process for the development of a SSS REMS or separate REMS and the determination that a SSS REMS or separate REMS is acceptable for final or tentative approval of the ANDA,” the document says.

The MAPP does not provide information on other agency actions and does not describe the policy, responsibilities, and procedures for developing a shared system REMS for multiple NDAs, ANDAs, or BLAs.