Advancing Generic Drug Development: Translating Science to Approval - Day 1 – Keynote and Session 1

This workshop focused on common issues seen in abbreviated new drug applications (ANDAs), link GDUFA science and research on complex products and scientific issues to product-specific guidance development, and pre-ANDA meeting discussions, and examined various areas of innovative science and cutting-edge methodologies behind generic drug development. This workshop also provided some insight into upcoming GDUFA III enhancements. Timestamps 00:47 – Keynote 14:16 – Guidance for Peptide Products and Assessing Immunogenicity Risk 34:14 – Common Deficiencies Associated with Comparative Peptide Impurity Profile Studies and Qualification of Impurity Levels and Proposed Limits 52:10 – Assessing Impurities to Inform Peptide Immunogenicity Risk: Developing Informative Studies 1:14:54 – Session 1A Question & Answer Panel Speakers: Robert Califf, MD Commissioner of Food and Drugs Food and Drug Administration (FDA) Eric Pang, PhD Senior Chemist DTP I | ORS | OGD | CDER Yili Li, PhD Chemist LBB II | DLBP I | OLDP | OPQ | CDER Daniela Verthelyi, MD, PhD Chief, Laboratory of Immunology DBRR III | OBP | OPQ | CDER Session Leads: Darby Kozak, PhD Deputy Director DTP I | ORS | OGD | CDER Cameron Smith, PhD Branch Chief LBB II | DLBP I | OLDP | OPQ | CDER Panelists: Same as above. 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