title: FDA scrutiny and pediatric clinical investigations.
authors.affiliation: Akin, Gump, Strauss, Hauer & Feld, L.L.P., USA.
authors.forename: M A
authors.initials: MA
authors.lastname: Kadzielski
authors.forename: J H
authors.initials: JH
authors.lastname: Gordon
mesh_terms: D000293:Adolescent; D002648:Child; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D005161:Facility Regulation and Control / Q000331:legislation & jurisprudence*; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D016134:Organizational Policy; D010372:Pediatrics / Q000331:legislation & jurisprudence / Q000592:standards*; D011367:Professional Staff Committees; D018570:Risk Assessment / Q000145:classification; D014481:United States; D014486:United States Food and Drug Administration