Dr. Dorothy Scott is a Supervisory Medical Officer, and Chief of the Plasma Derivatives Branch (PDB) in the Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies at the U.S. Food and Drug Administration. She received her M.D. from the University of Virginia, followed by internal medicine residencies at Strong Memorial Hospital (Rochester NY), and University of Maryland. Dr. Scott completed a Rheumatology fellowship at NIH and joined FDA as a researcher/regulator in 1993. Her regulatory group oversees more than 50 licensed products, including polyclonal Immune Globulins (IG), Alpha-1 Proteinase Inhibitor, C1 Esterase Inhibitors, antivenoms, antitoxins, and anti-thymocyte globulins. Her current research is focused on aspects of passive immunotherapy for infectious diseases (influenza, COVID-19), and on Immune Globulin-mediated hemolysis. Dr. Scott is also involved in regulatory and policy issues concerning adverse events, product supply, licensure of therapies under the Animal Efficacy Rule, “exotic”antivenoms, and orphan product development.