The first step of understanding vaccine regulation is to define what a vaccine is, explore how it differs from a traditional “drug,” review its regulatory history and statutory framework, and discuss how it is regulated by FDA’s Center for Biologics Evaluation and Research.
- Definition of a Vaccine
- “Drug” and “Biological Product”
- Vaccine Regulation History and Statutory Framework
- Role of FDA Center for Biologics Evaluation and Research
Julia C. Tierney, Partner, Latham & Watkins LLP
This session was recorded as part of FDLI’s Virtual Fundamentals of Vaccine Regulation Course in February 2021.