FDA Puts REMS Requirements on Hold to Ensure Continuity of Care

To ensure continuity of care for patients taking clozapine, the US Food and Drug Administration (FDA) will temporarily exercise "enforcement discretion" with respect to certain clozapine risk evaluation and mitigation strategy (REMS) program requirements.In a November 2 notice on its website, the FDA said it is aware that healthcare professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with patient access to clozapine following discharge from inpatient care.

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