title: The unfinished business of U.S. drug safety regulation.
authors.affiliation: Program in Pharmacogenomics, Ethics, and Public Policy, Indiana University Center for Bioethics, Indianapolis, IN, USA.
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Evans
authors.forename: David A
authors.initials: DA
authors.lastname: Flockhart
mesh_terms: D002983:Clinical Competence; D017047:Cost Sharing; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000458:organization & administration; D004353:Drug Evaluation, Preclinical; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards; D019983:Guideline Adherence; D006801:Humans; D019458:Insurance Coverage; D015271:Insurance Pools; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards; D012308:Risk Management; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration