title: The US Food and Drug Administration: a dysfunctional agency in need of major reforms.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Nissen
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007880:Legislation, Drug; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*