FDA announces comprehensive regenerative medicine policy framework

FDA on Thursday announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. The framework builds upon the agency's existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products.

FDA on Thursday announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. The framework builds upon the agency's existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products. Further, two of the four guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area. The suite of guidance documents also defines a risk-based framework for how FDA intends to focus its enforcement actions against those products that raise potential significant safety concerns. This modern framework is intended to balance the agency’s commitment to safety with mechanisms to drive further advances in regenerative medicine so innovators can bring new, effective therapies to patients as quickly and safely as possible. The two final guidance documents clarify the agency's interpretation of the risk-based criteria manufacturers use to determine whether a product is subject to FDA's premarket review. The two draft guidances provide information to help spur development and access to innovative regenerative therapies.