title: FDA draft guidance and health-outcomes research.
authors.affiliation: Center for Health Outcomes Research, United Biosource Corporation, Bethesda, MD 20814, USA. Dennis.Revicki@Unitedbiosource.com
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
mesh_terms: D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000379:methods*; D006287:Health Planning Guidelines; D006801:Humans; D010043:Outcome and Process Assessment, Health Care / Q000458:organization & administration*; D011788:Quality of Life; D014481:United States; D014486:United States Food and Drug Administration