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Structured Risk-Benefit Framework Strikes Back: FDA Suvorexant Reviewer Cites Need for Real World Predictions

This article was originally published in RPM Report

Executive Summary

A predictable risk-benefit framework for FDA drug approval decisions has been a long-term objective of many drug developers. A big step in that direction was adopted as part of the PDUFA V agreement last July. However, FDA's briefing documents for a review of a Merck insomnia therapy suggest that step may not be heading in quite the way that industry hoped.

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