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
In the keynote address at the 2025 Generic Drugs Forum, Darby Kozak of the FDA’s Office of Generic Drugs highlights the agency’s commitment to enhancing access to safe, effective generics through transparency and innovation. Kozak reviews 2024’s notable ANDA approvals—especially the first generic bupivacaine liposomal injection—as an example of FDA research translating into real-world impact. Key initiatives include a pilot program to improve communication on delayed applications, expanded support for complex bioequivalence studies, and a new online resource hub for industry guidance. Kozak emphasizes the vital importance of data integrity, urging industry accountability to maintain public trust and streamline approvals. The speech underscores the continued success of the GDUFA program in reducing barriers and approval timelines, ultimately benefiting U.S. patients by ensuring timely access to high-quality generic medications.