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Benefit-Risk Math: US FDA Still Favors Simple Calculations

 
• By Cole Werble

A core group of big pharma companies has been pressing FDA for over a decade to adopt a quantitative formula for conducting and communicating benefit-risk decisions. FDA has changed its benefit-risk calculations in response – but not its basic way of doing the math.

Mathematical scientific pattern

The US Food & Drug Administration is making steady progress to fulfill its commitment to deliver a draft guidance on benefit-risk decisions by 2020. The 2019 deliverable in that process was a May 16 meeting on “Benefit-Risk Assessment Through the Drug Lifecycle,” hosted by the Duke-Margolis Center for Health Policy.

The agency is committed to issuing a guidance on the topic as part of both the 21st Century Cures Act and the PDUFA VI user fee agreement – a sign...

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