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Most recent by Leah Hart, PharmD
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November 03, 2021
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FDA: Prescribers must certify, enroll outpatients in new clozapine REMS by Nov. 15
The FDA can require a safety program called a Risk Evaluation and Mitigation Strategy, or REMS, for a medication with serious safety concerns to ensure the benefits outweigh the risks. An REMS is designed to reinforce behaviors and actions that support safe use of that medication to mitigate a specific risk.