Jessica Greenbaum and Ruby Wu from the Office of Therapeutic Biologics and Biosimilars (OTBB) in CDER’s Office of New Drugs review biological products and regulation, labeling for biosimilar products, and labeling requirements for transition products.

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
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CDER small business e-mail update subscription: [ Ссылка ]

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