title: The 50th anniversary of the Kefauver-Harris Amendments: efficacy assessment and the randomized clinical trial.
authors.affiliation: Quintiles, Durham, NC, USA.
authors.forename: J Rick
authors.initials: JR
authors.lastname: Turner
mesh_terms: D049673:History, 20th Century; D006801:Humans; D007880:Legislation, Drug / Q000266:history*; D015201:Meta-Analysis as Topic; D017891:Pharmacoepidemiology; D016032:Randomized Controlled Trials as Topic / Q000266:history* / Q000331:legislation & jurisprudence*; D013723:Teratogens / Q000266:history; D013792:Thalidomide / Q000266:history; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history
chemical_list: D013723:Teratogens; D013792:Thalidomide