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Providers Embrace US FDA REMS Integration Plan But Wary Of Another iPledge ‘Failure’

 
• By Michael McCaughan

Providers are eager for the FDA to test integrating REMS requirements into electronic health records, but want the agency to ‘go slowly’ to avoid any disruptions along the way. Recent issues with two of the original restricted distribution plans in the US underscore the message of caution.

risk mitigation
Patients and providers stressed that back-up plans be in place when the new REMS integration software is tested. • Source: Shutterstock

The US Food and Drug Administration is being urged to move cautiously as it rolls out new software to integrate Risk Evaluation and Mitigation Strategy activities into existing workflows for prescribers, payors and pharmacies.

During a meeting hosted by the Duke-Margolis Center for Health Policy earlier this month, panelists representing providers and patients stressed...

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