title: Risk management: issues for outcomes research.
authors.affiliation: Center for Drug Evaluation & Research, Food and Drug Administration, Rockville, MD 20855, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D017850:Economics, Pharmaceutical; D006801:Humans; D017063:Outcome Assessment, Health Care; D012308:Risk Management / Q000458:organization & administration*; D014481:United States; D014486:United States Food and Drug Administration