hepatic injury / uncontrolled pneumonia / Pneumonia / central nervous system injury / /
Organization
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 / Food and Drug Administration / ICH Steering Committee / Communication Division of Drug Information / Center for Biologics Evaluation and Research / office of Training / Center for Biologics Evaluation and Research Food and Drug Administration / office of Communication / Training and Manufacturers Assistance / / /
Guidance for Industry M4: The CTD - Efficacy Questions and Answers