1. Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022 Subject(s): Antineoplastic AgentsBiological ProductsClinical Trials as TopicDrug Development -- legislation & jurisprudenceDrug Development -- standardsMedical OncologyUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
2. 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.
