New regulatory rules for clinical trials in the United States and the European Union: key points and comparisons.
Miossec
Marie
M
Edouard Herriot Hospital, Lyon, France.
Miossec
Pierre
P
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