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# CBER SOPP on Implementing, Managing REMS
- URL: https://www.fdaweb.com/cber-sopp-on-implementing-managing-rems/
- Published: 2026-07-06T12:00:00.000Z
- Updated: 2026-09-14T13:42:11.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, #legacy-id-D5161406

CBER has published a Standard Operating Policy and Procedure (SOPP) to guide staff in implementing and maintaining Risk Evaluation and Mitigation Strategies (REMS). The [document](ttps://www.fda.gov/media/133042/download?attachment) says the SOPP applies to an initial REMS as part of an original BLA or NDA, or a new REMS needed as part of an efficacy supplement. It also applies to:

- management and review of REMS revisions and minor/major modifications to an approved REMS;
- management and review of incoming REMS assessments for an approved REMS;
- management and review of incoming assessment instruments and methodology for an approved REMS; and
- management of a new REMS for an approved product based on new safety information.

The policy says the responsible product office and the CBER Office of Biostatistics and Pharmacovigilance (OBPV), Division of Pharmacovigilance, are to work together to determine when a REMS is required or if REMS modifications are needed. It further says thatCBER will generally consult CDER’s Office of Safety and Epidemiology, Division of Risk Management, for a new REMS to ensure cross-Center interpretation and implementation of REMS requirements. OBPV will determine whether a consult is needed for major REMS modifications or assessments, it says.