Clozapine REMS Program Paused After Problems With Re-Certification

 
• By Brenda Sandburg

US FDA says pharmacists may dispense the antipsychotic without a REMS authorization and wholesalers may continue to ship it during temporary suspension of REMS. A high call volume and long wait times have impacted patient access since the modified REMS launched on 15 November.

Clozapine form
FDA temporarily suspends requirements of clozapine REMS program • Source: Alamy

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