biological products / biologics license applications / prevention of a serious or life-threatening disease / drug product / improvement compared to marketed products / biological product / therapy for a disease / particular product / treatment protocol / drug products / treatment of a serious disease / /
treatment protocol / alternate therapies / alternative therapy / investigational therapies / surgery / /
Organization
U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Training and Communications Division of Drug Information / Food and Drug Administration / Center for Biologics Evaluation / office of Training / HFD-240 Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / office of Communication / Training and Manufacturers Assistance / / /
Guidance for Industry Available Therapy U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)