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Keynote and Industry Survey Results - GDUFA Science and Research Initiatives Public Workshop

Sally Choe, Ph.D., Director, Office of Generic Drugs (OGD) at CDER, provides the welcome address. Janet Woodcock, M.D., Acting Commissioner, FDA, provides the keynote. Robert Lionberger, Ph.D., Director, Office of Research and Standards, OGD, provides the introduction. Co-directors of the Center for Research on Complex Generics (CRCG) James Polli, Ph.D., and Anna Schwendeman, Ph.D., review industry feedback on science and research. 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 2021 Playlist -    • 2021 CDER Small Business and Industry...   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