REMS (Risk Evaluation and Mitigation Strategies)

REMS, or Risk Evaluation and Mitigation Strategies, are plans put in place by the Food and Drug Administration (FDA) to ensure that certain medications can be used safely. These strategies are designed for drugs that have significant risks, which might outweigh their benefits without proper management. REMS may include requirements like special training for healthcare providers, patient education, regular monitoring, or restricted distribution. The goal is to minimize risks while allowing patients access to necessary medications, ensuring that potential harms are managed effectively.