International Committee of Medical Journal Editors / U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Training and Communications Division of Drug Information / Food and Drug Administration / office of Training / HFD-240 Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / ICH Steering Committee / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / office of Communication / Training and Manufacturers Assistance / / /