FDA Eliminates the Clozapine REMS—What Comes Next?
Deanna L. Kelly, John M. Kane, Raymond C. Love, Robert O. Cotes
Abstract
This Viewpoint provides suggestions to address challenges after elimination of the Clozapine Risk Evaluation and Mitigation Strategies (REMS) system by the US Food and Drug Administration (FDA).
Topics & Concepts
ClozapineFood and drug administrationMedicineDrugPharmacologyIntensive care medicineSchizophrenia (object-oriented programming)PsychiatrySchizophrenia research and treatmentHealth Systems, Economic Evaluations, Quality of LifeMental Health and Psychiatry