title: US regulation of pharmaceutical outcomes research.
authors.affiliation: Evidence Review Branch, Division of Drug Marketing, Advertising and Communications, Food and Drug Administration, 5600 Fishers Lane, Mail Stop HFD-42, Rockville, MD 20857, USA. burkel@cder.fda.gov
authors.forename: L B
authors.initials: LB
authors.lastname: Burke
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000331:legislation & jurisprudence*; D011788:Quality of Life; D014481:United States; D014486:United States Food and Drug Administration