title: Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance.
authors.affiliation: Formerly with the US Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D002986:Clinical Trials as Topic; D003657:Decision Making; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D006801:Humans; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000592:standards*; D035501:Uncertainty; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*