Back to: FDA Generic Drugs Forum 2025
Presenter
Darby Kozak, PhD
Deputy Director
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Darby Kozak is the Deputy Director for the Office of Generic Drugs where he serves as a senior agency advisor in the development and implementation of FDA policies and long-range objectives for generic drug scientific programs and activities, including the development of a strategic plan for the Generic Drug Program. Prior to joining the FDA, Dr. Kozak was Chief Scientist for Izon Science and Research Fellow at The University of Queensland’s 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).
Abstract
At the 2025 Generic Drugs Forum, Dr. Darby Kozak presents a comprehensive overview of current challenges and opportunities for improving ANDA submission quality and review efficiency. Emphasizing the need to reduce review cycles, he shares retrospective data from FY 2018 and FY 2022 to highlight persistent major deficiencies, particularly in manufacturing site facilities. He examines trends across industry size and product complexity, noting rising submissions of complex generics and increased reliance on in vitro bioequivalence studies. Dr. Kozak identifies common gaps in method development and validation, especially in topical dermatological products, and underscores the importance of FDA-industry engagement through GDUFA resources, guidance documents, and workshops. He advocates for proactive communication, strategic use of FDA programs, and leveraging research insights to drive first- and second-cycle approvals.