Risk Evaluation and Mitigation Strategies (REMS) are regulatory requirements imposed by the FDA to ensure that the benefits of certain high-risk drugs or medical devices outweigh their risks. REMS programs identify potential safety concerns and implement risk management tools—such as provider certification, patient monitoring, and restricted distribution—to protect patients and ensure safe use throughout treatment. Pharmaceutical companies and healthcare providers must understand and comply with REMS guidelines to maintain patient safety and regulatory approval.

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