REMS

REMS, or Risk Evaluation and Mitigation Strategies, is a plan required by the FDA to ensure that certain medications with serious safety concerns are used safely. It helps healthcare providers and patients understand and manage potential risks, such as side effects or misuse. REMS may include special training, certification, or monitoring programs. The goal is to balance the benefits of a medication with its risks, ensuring it is used appropriately while minimizing harm. Not all medicines have REMS; it mainly applies to drugs with higher safety concerns.