REMS (Risk Evaluation and Mitigation Strategy)

REMS, or Risk Evaluation and Mitigation Strategy, is a plan required by the FDA for certain medications to ensure they are used safely. It helps balance benefits and risks by implementing measures such as special training, monitoring, or restrictions on how the drug is accessed or administered. The goal is to minimize potential serious side effects or misuse while allowing patients who need the medication to benefit from it. REMS programs are tailored to each drug's specific safety concerns and are designed to protect patients and healthcare providers.