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The New Drug Approval Process: Basic Concepts

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Recorded November 2023 | On-Demand Webinar
Access to recordings of virtual introductory courses is limited to one year from the date of purchase as we update programs annually.

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.

This session was recorded as part of FDLI’s virtual Introduction to Drug Law and Regulation course in November 2023.

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