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# REMS MAPP Issued
- URL: https://www.fdaweb.com/rems-mapp-issued/
- Published: 2019-02-07T12:00:00.000Z
- Updated: 2026-09-15T01:01:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143326

CDER has issued a Manual of Policies and Procedures (MAPP) on the responsibilities and procedures for developing a single, shared system risk evaluation and mitigation strategy (REMS) or a separate REMS with elements to assure safe use. The [MAPP](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM630912.pdf?ref=fdaweb.com) does not include information on other agency actions, such as complete response letters, associated with particular applications. It also does not describe the policy, responsibilities, and procedures for developing a shared systems REMS for multiple NDAs or ANDAs or multiple BLAs, submitted under specific sections of the Federal Food, Drug, and Cosmetic Act, that form a shared system REMS voluntarily or at the request of the agency.