title: A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report.
authors.affiliation: Cardiovascular Health Research Unit, Department of Medicine, University of Washington and Group Health Research Institute, Group Health Cooperative, Seattle, Washington 98101, USA. psaty@u.washington.edu
authors.forename: Bruce M
authors.initials: BM
authors.lastname: Psaty
authors.forename: Eric M
authors.initials: EM
authors.lastname: Meslin
authors.forename: Alasdair
authors.initials: A
authors.lastname: Breckenridge
mesh_terms: D017277:Drug Approval; D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*