FDA Briefing Document: Risk Evaluation & Mitigation Strategy (REMS) For Clozapine Products

The document was presented at the November 19, 2024, meeting of the Joint Meeting of the FDA Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee Meeting. The committee discussed the FDA's reevaluation of the Risk Evaluation and Mitigation Strategy (REMS) for the antipsychotic clozapine which required regular blood tests to monitor for the risk of severe neutropenia. The committee was asked to consider if the education requirements to prescribe and dispense clozapine could safely be simplified, reduced in scope, or even eliminated without reducing consumer safety . . .