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. Master protocols: efficient clinical trial design strategies 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 Trial Protocols as TopicClinical Trials as TopicUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
3. Oncology drug products used with certain in vitro diagnostic tests: pilot program : guidance for industry, clinical laboratories, and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, June 20, 2023 Subject(s): Antineoplastic AgentsDrug IndustryGovernment RegulationIn Vitro TechniquesUnited StatesUnited States. Food and Drug Administration
