US regulation of pharmaceutical outcomes research.
Burke
L B
LB
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
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