Recognize the difference between a “drug” and a “new drug” under the Federal Food Drug and Cosmetic Act (FDCA). Learn the various approval pathways for bringing a new drug to the U.S. market. Understand the scientific standards by which FDA will approve a new drug.
Nathan A. Beaton, Associate, Latham & Watkins LLP
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in April 2022.