Risk Evaluation and Mitigation Strategies (REMS)
Also known as: REMS, REMS program
Verified from FDA on 06-02-2026Risk Evaluation and Mitigation Strategies, commonly abbreviated as REMS, are safety programs that the U.S. Food and Drug Administration can require for specific drugs or biological products when additional measures are needed to support safe use beyond standard labeling. A REMS may include elements such as medication guides, communication plans, or restricted distribution requirements. The verbatim notice from the FDA source page is reproduced below for reference.
MedivaScan summary. The authoritative source quote follows below.FDA definition
NOTICE — May 20, 2025: HHS modified this webpage pursuant to Executive Order 14168, but has reevaluated this webpage for purposes of compliance with Executive Order 14168, the Paperwork Reduction Act, the Information Quality Act, and the Foundations of Evidence-Based Policymaking Act of 2018. Based on that evaluation, HHS is temporarily restoring the information on this page as it existed on January 31, 2025, with certain modifications to account for new and amended Risk Evaluation and Mitigation Strategies (REMS) that were approved between January 31, 2025, and the present. Although HHS did not conclude that modification of this website was inconsistent with any of the aforementioned statutes, HHS is providing notice of anticipated changes. After a period of at least two weeks from the date of this notice, information on this page will be modified and/or removed.