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. Q5A(R2): viral safety evaluation of biotechnology products derived from cell lines of human or animal origin : guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, January 2024 Subject(s): BiotechnologyCell LineDrug IndustryGovernment RegulationSafetyVirus DiseasesUnited States
