Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 3

This public workshop communicated how FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program outcomes guide and facilitate generic drug development, regulatory assessment, and approval. Day two, part three covers session seven: Enhanced Processes, Research, and Assessment Tools to Support Generic Drug Product Development. Timestamps 00:54 – GDUFA Research Program: Research Priorities to Support Generic Drug Development 15:58 – Identify Research Needs and PSG Development for Complex Products 29:44 – Enhance Communication in Using Modeling Approaches in ANDAs 45:04 – Session 7 Q&A Discussion Panel Speakers: Sam Raney, PhD Associate Director for Science Office of Research and Standards (ORS) Office of Generic Drugs (OGD) Center for Drug Evaluation and Research (CDER) | FDA Xiaoming Xu, PhD Division Director Division of Product Quality Research (DPQR) Office of Testing and Research (OTR) Office of Pharmaceutical Quality (OPQ) CDER | FDA Liang Zhao, PhD Division Director Division of Quantitative Methods and Modeling (DQMM) ORS | OGD | CDER | FDA Panelists: Sam Raney, Xiaoming Xu, Liang Zhao, and Darby Kozak, PhD Deputy Division Director Division of Therapeutic Performance I (DTP I) ORS | OGD | CDER | FDA Robert Lionberger, PhD Director ORS | OGD | CDER | FDA Zhen Zhang, PhD Master Pharmacologist Division of Bioequivalence I (DB I) Office of Bioequivalence (OB) OGD | 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 2022 Playlist -    • 2022 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