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. Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019 Subject(s): Anti-Infective AgentsDevice ApprovalDrug ApprovalDrug DevelopmentMicrobial Sensitivity TestsDrug IndustryBiotechnologyHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
