Benefit-Risk Math: US FDA Still Favors Simple Calculations

The US Food & Drug Administration is making steady progress to fulfill its commitment to deliver a draft guidance on benefit-risk decisions by 2020.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 of the continuing pressure on the agency from drug sponsors for a