The FDA recently announced a novel policy for the development of regenerative medicine products. The policy adds to the existing risk-based regulatory approach to define what products are characterized as drugs, devices, and biologics, according to a press release.
“We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease,” said FDA Commissioner Scott Gottlieb, MD. “This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.”
More details here.