Advancing Generic Drug Development: Translating Science to Approval 2024 September 24 - 25, 2024

https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-translating-science-approval-2024-09242024?utm_medium=email&utm_source=govdelivery Join us for the 2024 Advancing Generic Drug Development workshop. FDA experts will discuss and analyze the complex scientific issues encountered in generic drug development and abbreviated new drug applications (ANDAs). This workshop promises to be an invaluable opportunity to: Gain insights into GDUFA III updates and the latest scientific research on complex products Explore product-specific guidance development, pre-ANDA, and ANDA meeting discussions Discover innovative science and cutting-edge methodologies driving generic drug development We hope you can join us in person! In-person attendees will engage with FDA scientists during a poster session, featuring topics such as: Research supporting guidance development Advanced analytical methods PBPK modeling Post-market surveillance ANDA assessment And more!