Biological Product Approval, Vaccines, Emergency Use Authorization: An Introduction
A session from FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More
Recorded March 5–6, 2024
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.
Elizabeth Trentacost, Senior Associate, Arnold & Porter LLP
This session was recorded as part of FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Course in March 2024.
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