Bloomberg Law
July 20, 2020, 5:50 PM

Stem Cell Companies Get Extra Grace Period for FDA Review

Jeannie Baumann
Jeannie Baumann

Stem cell developers now have until the end of next May to bring their products to the FDA, after the agency extended a grace period by another six months amid the pandemic.

The Food and Drug Administration announced Monday it’s pushing back to May 31, 2021, a deadline to determine if stem cell and other cell and tissue companies need to apply for approval to conduct clinical trials or put their products on the market. The extension follows up on a 2017 regenerative medicine policy that targeted for-profit stem cell clinics selling unproven and potentially harmful therapies. It doesn’t apply ...