REMS Assessment Review Goals, Resources On The Table For PDUFA VII

 
• By Derrick Gingery

US FDA proposes formal performance metrics for REMS assessment reviews, which would be part of a larger campaign to streamline the REMS assessment process.

Risk versus value matrix with pushpins and blur effect. Concept of investment risk assessment.
The FDA wants more PDUFA resources devoted to the REMS program to help speed up REMS assessment reviews. • Source: Shutterstock

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