Orange Book An Overview of Therapeutic Equivalence

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Elizabeth Friedman from the Office of Generic Drugs discusses the basics of therapeutic equivalence and how FDA determines if drug products are therapeutically equivalent (TE). • • 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 2020 Playlist - https://www.youtube.com/playlist?list... • SBIA LinkedIn -   / cder-small-business-and-industry-assistance     • SBIA Training Resources - https://www.fda.gov/cderbsbialearn   • Twitter -   / fda_drug_info     • Email - [email protected]   • Phone - (301) 796-6707 I (866) 405-5367

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