1. Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017 Subject(s): Antibacterial AgentsAntifungal AgentsDrug Labeling -- standardsInvestigational New Drug ApplicationMicrobial Sensitivity TestsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Limited population pathway for antibacterial and antifungal drugs Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020 Subject(s): Anti-Bacterial AgentsAntifungal AgentsLegislation, DrugUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.