AGDD 2025 | D2S05 - Workshop Closing Remarks

FDA experts demonstrated the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. This workshop dissected complex scientific challenges in abbreviated new drug applications (ANDAs), and provided insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues related to product-specific guidance development, as well as pre-ANDA and ANDA meeting discussions. Timestamps 01:05 – Workshop Closing Remarks Speakers: Lei Zhang, PhD Deputy Office Director Office of Research and Standards (ORS) Office of Generic Drugs (OGD) Center for Drug Evaluation and Research (CDER) | FDA Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry Assi...   SBIA 2025 Playlist -    • 2025 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367