DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / European Federation of Pharmaceutical Industries Associations / Committee for Proprietary Medicinal Products / office of Health Affairs / World Health Organization / ICH Secretariat / Independent Data Monitoring Committee / U.S. Food and Drug Administration / Availability AGENCY / Japanese Pharmaceutical Manufacturers Association / European Commission / FDA / European Union / Center for Drug Evaluation and Research / ICH Steering Committee / Center for Biologics Evaluation and Research / Centers for Drug Evaluation and Research and Biologics Evaluation / Ministry of Health / International Federation of Pharmaceutical Manufacturers Associations / office of Communication / Training and Manufacturers Assistance / /