1. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2017 Subject(s): Anti-Bacterial Agents -- therapeutic useBacterial Infections -- drug therapyDrug ApprovalDrug Resistance, BacterialInvestigational New Drug ApplicationClinical Trials as TopicHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.