Darby Kozak, PhD, is the Acting Director of FDA’s Office of Generic Drugs (OGD) within the Center for Drug Evaluation and Research (CDER). OGD is responsible for the review and approval of abbreviated new drug applications (ANDAs) and is committed to ensuring, through a rigorous scientific and regulatory process, that generic drugs are safe and effective for the American public.
Dr. Kozak has over a decade of FDA and generic drug experience. He began his FDA career in OGD’s Office of Research and Standards, where he developed new analytical methods and equivalence evaluation methodologies for complex generic drug substances and a range of formulations, including parenteral, ophthalmic, otic, and inhalation products. Throughout his FDA career, Dr. Kozak has contributed to key industry guidances, advanced generic drug development through GDUFA science and research priorities, and led strategic initiatives that directly support GDUFA goals and help ensure American patients have timely access to safe, affordable, quality generics.
Prior to joining FDA, Dr. Kozak served as Chief Scientist for Izon Science and as a Research Fellow at the University of Queensland’s Australian Institute for Bioengineering and Nanotechnology. He holds a B.Sc. in Chemical Engineering from the University of Washington and a Ph.D. in Chemistry, specializing in Physical Chemistry and Colloid and Surface Science, from the University of Bristol, United Kingdom.
