Risk Evaluation and Mitigation Strategies (REMS)

Risk Evaluation and Mitigation Strategies (REMS) are plans required by the U.S. Food and Drug Administration (FDA) for certain medications that have significant risks, such as serious side effects or potential misuse. REMS aim to ensure that the benefits of a drug outweigh its risks. They may include patient education, restricted distribution, or regular monitoring by healthcare providers. By implementing these strategies, the FDA helps ensure that patients use these medications safely and effectively, minimizing potential harm while allowing access to necessary treatments.