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# MAPP on REMS Development
- URL: https://www.fdaweb.com/mapp-on-rems-development/
- Published: 2020-10-28T12:00:00.000Z
- Updated: 2026-09-14T16:34:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147973

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](https://www.fda.gov/media/123900/download?ref=fdaweb.com) 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.