FDA unveils regenerative medicine policy framework

FDA unveiled a regenerative medicine framework on Thursday aimed at speeding the development and review of cell - and tissue-based therapies, including gene therapies, while also cracking down on those that would game the system. The framework, which was outlined in two draft and two final guidances, builds on the agency's previous policy that took effect in 2005.

"Today we’re taking steps to advance an innovative framework for how we intend to apply the existing laws and regulations that govern these products," FDA Commissioner Scott Gottlieb said in a statement. "Our aim is to make sure we’re being nimble and creative when it comes to fostering innovation, while taking steps to protect the safety of patients."...