title: [FDA's new drug approval system].
authors.forename: A
authors.initials: A
authors.lastname: Ishii
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D017277:Drug Approval / Q000191:economics; D004341:Drug Evaluation; D009965:Orphan Drug Production; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration