Structured Risk-Benefit Framework Strikes Back: FDA Suvorexant Reviewer Cites Need for Real World Predictions
This article was originally published in RPM Report
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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Sponsors may need to be more proactive in reaching out to the agency if they want to avoid the kind of dosing confusion currently facing Merck’s insomnia drug suvorexant, FDA indicates.
Drug reviews will include a benefit-risk summary assessment that states the rationale for regulatory action on a drug or biologic application and explains how differences of opinion among reviewers were resolved.