1. Development of anti-infective drug products for the pediatric population Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2021 Subject(s): Anti-Infective AgentsDrug DevelopmentPediatricsUnited StatesUnited States. Department of Health and Human ServicesUnited 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.