title: New regulatory rules for clinical trials in the United States and the European Union: key points and comparisons.
authors.affiliation: Edouard Herriot Hospital, Lyon, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Miossec
authors.forename: Pierre
authors.initials: P
authors.lastname: Miossec
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000379:methods*; D028741:Ethics Committees, Clinical; D005062:European Union; D033161:Government Regulation; D006801:Humans; D014481:United States