Learn about the Biologics License Application (BLA) and how it differs from Emergency Use Authorization. Understand FDA’s review and decision process. Learn the fundamentals of vaccine regulation and how it’s regulated by FDA’s Center for Biologics Evaluation and Research (CBER). Understand the different pathways to market.
Jessica Greenbaum, Counsel, King & Spalding LLP
Eva Temkin, Partner, King & Spalding LLP
This session was recorded as part of FDLI’s Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in October 2022.
JESSICA GREENBAUM is a Counsel in King & Spalding’s FDA and Life Sciences practice in Washington, D.C. Prior to joining King & Spalding, Jessica served as a Regulatory Counsel in FDA’s Office of Therapeutic Biologics and Biosimilars. In that position, Jessica developed and implemented regulatory policy related to biosimilars and other therapeutic biological products, including with respect to combination products, biosimilar labeling, reference product exclusivity, the Purple Book, and the review and approval of biologics license applications.
EVA TEMKIN is a partner in King & Spalding’s FDA and Life Sciences practice where she counsels clients regarding complex issues associated with FDA-regulated biomedical products. Eva draws upon her deep experience with these products at FDA to help clients navigate development, approval, post-market regulation and life-cycle management of drugs and biologics, biosimilars and combination products. Prior to joining K&S, Eva acted as Director for Policy at FDA’s Office of Therapeutic Biologics and Biosimilars. In that position, Eva was the Agency lead for the Biosimilars Action Plan and oversaw policy development related to biosimilars and other therapeutic biologics.Get Access
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