The New Drug Approval Process: New Drug Research and Development

Learn the requirements of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). Understand the fast-track review process. Learn the requirements for pediatric testing and orphan drugs.

Justin A. Coen, Partner, Venable LLP

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

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