Regulatory Highlights for Biosimilars and Interchangeables (9of15) REdI – May 29-30, 2019

Eva Temkin from CDER’s Office of New Drugs shares an overview of FDA’s perspective on the regulatory considerations applicable to development of biosimilar and interchangeable products under section 351(k) of the Public Health Service Act. She covers FDA’s biosimilars action plan, biological regulatory modernization, and recently-issued guidance including the updated draft guidance on nonproprietary naming of biological products.

Learn more at https://www.fda.gov/drugs/cder-small-...


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