Risk Evaluation and Mitigation Strategy

A Risk Evaluation and Mitigation Strategy (REMS) is a plan developed by a drug manufacturer to ensure that a medication is used safely and effectively. It identifies potential risks associated with the drug and outlines specific steps—such as special training, monitoring, or restrictions—to minimize those risks. REMS helps healthcare providers and patients use the medication appropriately, reducing chances of harm while ensuring the drug benefits outweigh its risks. Essentially, it's a proactive approach to managing safety concerns related to certain medicines.