ARTICLE | Politics & Policy

FDA to hold workshop on structured benefit-risk assessment

August 8, 2017 11:50 PM UTC

FDA will hold a public workshop on Sept. 18 to discuss the structured assessment of benefit and risk for drug and biologic candidates under review. The workshop will discuss regulatory and industry experiences with structured benefit-risk assessments and methods for incorporating patient perspectives. The meeting will also explore more systematic and structured approaches to evaluating benefits and risks, and their implications on regulatory decisions. Comments on the topic are due Nov. 18...