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.
Jennifer A. Davidson, Partner, Kleinfeld, Kaplan & Becker, LLP
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in November 2022.