FDA Guidance for Cell and Gene Therapy: Insights from Peter Marks at CGT Summit 2023
Автор: Charles River Labs
Загружено: 2025-10-22
Просмотров: 37
Описание:
In this keynote from the 2023 CGT Summit hosted by Charles River Laboratories, Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), shares his vision for the future of cell and gene therapy. He addresses key regulatory challenges, including FDA cell and gene therapy guidance, global harmonization, and manufacturing scalability. The session explores how CDMOs can support innovation, the role of CGT FDA guidance in accelerating approvals, and the evolving landscape of cell therapy and gene therapy regulations. A must-watch for anyone navigating rare disease development and regulatory strategy.
https://bit.ly/3KZo06I
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