U.S. Department of Health and Human Services / office of Communication / Outreach and Development / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Center for Biologics / Food and Drug Administration 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 / office of Communications Division of Drug Information / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / /