1. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders Publication: Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, January 2017 Subject(s): Civil Defense -- legislation & jurisprudenceDevice ApprovalDrug ApprovalEmergenciesTerrorismEmergency Medical ServicesEquipment SafetyOff-Label UsePublic HealthSafetyHumansUnited StatesUnited States. Department of Health and Human Services.United States. Department of Homeland Security.United States. Food and Drug Administration.
2. Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies: guidance for industry, investigators, and institutional review boards Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023 Subject(s): Clinical Trials as TopicDisastersEmergenciesGovernment RegulationPublic HealthUnited States