1 U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Biotechnology Review and Research 1, Silver Spring, MD, USA. Electronic address: [email protected].
2 U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Biotechnology Review and Research 1, Silver Spring, MD, USA.
3 U.S. Food and Drug Administration, Center for Biologicals Evaluation and Research, Facility for Biotechnology Resources, Silver Spring, MD, USA.
4 U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Hematology and Oncology Products, Silver Spring, MD, USA.
5 U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, HIVE, Silver Spring, MD, USA.