Final guide changes US FDA policy on requiring drug medication guides in REMS
This article was originally published in SRA
Executive Summary
A final guidance document from the US Food and Drug Administration has confirmed that manufacturers are no longer expected to always include a medication guide in their risk evaluation mitigation strategy (REMS) programme1,2. The guidance also explains when medication guides should be provided with prescription drugs or biologics that are dispensed to a healthcare professional for administration in an inpatient setting.