BioCentury
ARTICLE | Strategy

FDA’s regeneration

What the regenerative medicine industry wants from FDA this September

July 27, 2017 9:51 PM UTC

With $500 million and a bipartisan mandate to innovate regulatory science courtesy of the 21st Century Cures Act, FDA Commissioner Scott Gottlieb has made regenerative medicine a focal point of the agency’s Innovation Initiative, and promised to issue comprehensive guidelines for cell therapies in September. That is music to the ears of companies looking for clear boundaries and new ways to demonstrate efficacy for their regenerative therapies.

In a July 7 post on the agency’s blog, Gottlieb wrote the framework will “delineate our policies for appropriate and efficient regulatory oversight of regenerative medicine products.” He said the proposed suite of guidance documents will use FDA’s existing regulations as a foundation to provide clarity to sponsors, and that they will build upon the current framework and work toward implementing the provisions of the 21st Century Cures Act...