Affiliation: | 1. Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland, USA;2. Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA;3. Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA;4. Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland, USA Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA |