Back to: FDA Generic Drugs Forum 2025
Presenter
Joseph Kotsybar, PharmD
Regulatory Health Project Manager, Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Joseph (Joe) Kotsybar graduated from Southern Illinois University, Edwardsville, with two Bachelors of Science in Chemistry and Biological Sciences. After graduation, he spent several years as a Production Chemist. Joe continued his post-graduate education and graduated from St. Louis College of Pharmacy with a Doctor of Pharmacy (Pharm.D.) degree. While completing his Pharmacy Degree, he worked as a Visiting Student Researcher at Washington University School of Medicine’s Radiation Oncology Lab.
Joe began with the FDA in 2020 as an ORISE fellow with research focusing on tracking of PSG Generic Drug User Fee Amendments (GDUFA) commitment measurables and ICH M13A implementation. In his current role, Joe serves as the current acting-lead for the Product-Specific Guidance (PSG) program.
Abstract
Joseph Kotsybar discusses the FDA’s Product-Specific Guidance (PSG) program at the Generic Drugs Forum 2025, explaining its role in supporting the development of generic drugs that are therapeutically equivalent to reference listed drugs (RLDs). He highlights the PSG process, the impact of GDUFA III commitments, and the adoption of the M13A guideline, which streamlines bioequivalence study requirements for immediate-release oral dosage forms. Kotsybar emphasizes the importance of public engagement through requests, comments, and meetings, and the availability of forecasting tools to assist in drug development planning. He also covers the cyclical nature of PSG publication, with new and revised guidances published quarterly or as standalone batches. The presentation underscores the FDA’s efforts to collaborate with the industry to reduce costs and improve efficiency in generic drug development.