Recognize the requirements of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). Explore the fast track review process. Discuss pediatric testing requirements, orphan drug requirements, and 21st Century Cures Act developments.
Marian J. Lee, Partner, Gibson, Dunn & Crutcher LLP
This session was recorded as part of FDLI’s Virtual Introduction to Drug Law and Regulation Course in April 2021.