Autologous cell therapies: challenges in US FDA regulation

Written by Regenerative Medicine

Read this Opinion, published in Regenerative Medicine, to understand why after 30 years of laboratory and clinical efforts fueled by countless billions in public and private funding, cell-based therapies have not made a greater impact. The current regulatory environment, with its zero-risk stance, stymies clinical innovation while fueling a potentially risky medical tourism industry. In this Opinion, published in Regenerative Medicine, the authors highlight the challenges the US FDA faces and present talking points for an improved regulatory framework for autologous cell-based therapies. McAllister TN, Audley D, L’Heureux N. Autologous cell therapies: challenges in US FDA regulation. Regen. Med. 7(6...

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