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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

Risk Evaluation and Mitigation Strategy assessments may be subject to performance goals under the next prescription drug user fee program.

Food and Drug Administration officials also have indicated they want funding to speed up the REMS assessment process. As part of PDUFA VII, the agency proposed additional “resources that would be needed to enable CDER and CBER to move more quickly to implement program improvements,” according to

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