title: Remarks at the Food and Drug Law Institute's 48th Annual Conference.
authors.affiliation: Office of Regulatory Affairs, Food and Drug Administration (FDA), Rockville, MD, USA.
authors.forename: Steven M
authors.initials: SM
authors.lastname: Niedelman
mesh_terms: D003415:Crime; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards; D011307:Drug Prescriptions; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D005607:Fraud; D007391:International Cooperation; D007880:Legislation, Drug; D012308:Risk Management; D014481:United States; D014486:United States Food and Drug Administration