Tag: risk mitigation strategies
REMS Programs: Understanding FDA’s Risk Evaluation and Mitigation Strategies for High-Risk Medications
Posted by Elias Kellerman in Medications
25Dec
REMS programs are FDA-mandated safety systems for high-risk medications that require extra controls like prescriber certification, patient registries, and lab monitoring. Learn how they work, why they cause delays, and what’s changing to improve access.
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