Revising the Regulation of Stem Cell-Based Therapies: Critical Assessment of Potential Models.

The regulation of stem cell-based therapies is challenging in many respects, given their unique safety, efficacy, and quality issues. At the same time, public interest in these innovative therapies has led some to question FDA's regulation of them, while others urge strict regulation and stronger enforcement. Within the context of this broader debate, this article examines recent attempts in other jurisdictions to craft specific provisions allowing additional flexibility in regulating cell and tissue therapies: Australia's exemption for autologous cell and tissue therapies, and the hospital exemption in Europe's regulation for advanced therapies.