U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Drug Information HFD-240 Center for Drug Evaluation / Food and Drug Administration / office of Training / Training and Communications Division / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / Organization of the CTD M4E / Center for Biologics Evaluation and Research / Organization of an ANDA / Center for Biologics Evaluation and Research Food and Drug Administration / office of Communication / Training and Manufacturers Assistance / /
Guidance for Industry Submitting Marketing Applications According to the ICH-CTD Format —