1. 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.
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
