1. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination Publication: Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, October 2019 Subject(s): Clinical Trials as TopicDevice ApprovalDrug ApprovalInvestigational New Drug ApplicationMedical OncologyReagent Kits, Diagnostic -- standardsDrugs, InvestigationalHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
