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Bioequivalence Regulations and Product-Specific Guidances

Dave Coppersmith from the Office of Generic Drug Policy discusses bioequivalence (BE) regulatory requirements and how they relate to product specific guidances (PSGs), the availability of alternative approaches to recommendations in PSGs, in vivo and in vitro BE testing requirements, and how FDA revises PSGs. Learn more at https://www.fda.gov/drugs/fda-product... _______________________________   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-assistanc...   SBIA Training Resources - https://www.fda.gov/cderbsbialearn    Twitter -   / fda_drug_info      Email - [email protected]    Phone - (301) 796-6707 I (866) 405-5367