Two FDA committees voted to eliminate monitoring requirements in the REMS program for clozapine, a medication for treatment-resistant schizophrenia. The drug can cause severe neutropenia, but the committees felt that the monitoring requirements were not necessary for safe use. The vote was overwhelmingly against the requirements, with panel members citing the reduction of burden on healthcare professionals and the removal of barriers to prescribing the drug as reasons for their decision. The decision was made during a joint meeting of the Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee on November 19, 2024.
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FDA committees strike down monitoring requirements for schizophrenia drug
