title: The prescription drug user fee act: active postmarketing drug surveillance and safety.
authors.forename: Alan
authors.initials: A
authors.lastname: Lyles
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration / Q000191:economics*