Introduction to Vaccine Regulation

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.

  1. Definition of a Vaccine
  2. “Drug” and “Biological Product”
  3. Vaccine Regulation History and Statutory Framework
  4. 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. 



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