Biological Product Approval, Vaccines, Emergency Use Authorization: An Introduction
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.
Christina M. Markus, Partner, King & Spalding LLP
Jessica Greenbaum, Counsel, 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 2023.