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.
Get Access
- +$100 for nonmembers
Internet Explorer and Microsoft Edge are not supported by the checkout process.
Please use Chrome, Firefox, or Safari. If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.
Virtual Learning FAQ
Related Content