1. Anthrax: developing drugs for prophylaxis of inhalational anthrax Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018 Subject(s): Anthrax -- drug therapyAnthrax -- prevention & controlAntibiotic ProphylaxisClinical Trials as TopicDrug Evaluation, Preclinical -- standardsDrugs, Investigational -- therapeutic useInhalation ExposureAdultChildEndpoint DeterminationMicrobial Sensitivity Tests -- standardsPediatricsProduct Surveillance, Postmarketing -- standardsResearch DesignHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Antimicrobial susceptibility test (AST) system devices: updating breakpoints in device labeling : guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2023 Subject(s): Government RegulationMedical Device LegislationMicrobial Sensitivity Tests -- standardsProduct LabelingUnited States