U.S. Department of Health and Human Services / 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 / Training and Communication Division of Drug Information / Food and Drug Administration Center for Drug Evaluation and Research / CIOMS V / Food and Drug Administration / ICH Steering Committee / Center for Biologics Evaluation and Research / office of Training / Center for Biologics Evaluation and Research Food and Drug Administration / Council for International Organizations of Medical Sciences / office of Communication / Training and Manufacturers Assistance / / /
Guidance for Industry: Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs