title: Global regulatory issues.
authors.affiliation: US Food and Drug Administration, US Department of Health and Human Services, USA.
authors.forename: Murray M
authors.initials: MM
authors.lastname: Lumpkin
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards; D004335:Drug and Narcotic Control / Q000379:methods*; D006077:Government Agencies; D007391:International Cooperation; D028701:Patient Rights