Deputy Division Director
US Food and Drug Administration
Dr. Darby Kozak is the Deputy Division Director for the Division of Therapeutic Performance One in the FDA’s Office of Generic Drugs. Dr. Kozak leads a group of interdisciplinary scientists on the development of new analytical methods and methodologies to evaluate the equivalence of complex generic drug substances and complex generic parenteral, ophthalmic, otic, and inhalation formulations. Prior to joining the FDA, Dr. Kozak was Chief Scientist for Izon Science and Research Fellow at the Australian Institute for Bioengineering and Nanotechnology. Dr. Kozak has a B.Sc. in Chemical Engineering from the University of Washington (Seattle, WA) and Ph.D. in Chemistry from the University of Bristol (United Kingdom).