The REMS, originally designed to reduce the risk of clozapine-related neutropenia, has instead created substantial and avoidable barriers to basic care. As part of this REMS program, prescribers ...
Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window Most physicians said the positives of clozapine's REMS outweighed its negatives. Most also said that mandatory blood ...
In November, an FDA advisory panel voted 14-1 against key regulatory aspects of the Clozapine Risk Evaluation and Mitigation Strategy, or REMS. The panel determined that REMS, the centralized ...
Only drugs with inpatient-applicable REMS requirements were included in the initial evaluation. Of the 145 drugs evaluated, 123 were excluded from the project because the associated REMS were ...
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