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Beyond The REMS: Clozapine Adcomm Shows Why In-Program Assessments Are Not Always Enough

 
• By Sue Sutter

The FDA and sponsors should have surveyed providers and patients who do not prescribe or use the antipsychotic clozapine to find whether the REMS restrictions were hindering access and causing harm, advisory committee members and patient advocates said.

Eye glasses focused
Schizophrenics are suffering because of the FDA's "myopic" focus on absolute neutrophil counts with clozapine, patient advocates said. (Shutterstock)

Sometimes you have to look outside a drug’s Risk Evaluation and Mitigation Strategy to evaluate the program, advisory committee members and patient advocates told the US Food and Drug Administration.

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