Posted by Michael Wonder on 19 Jul 2017
U.S. FDA designates Mallinckrodt's StrataGraft as regenerative medicine advanced therapy
18 July 2017 - Provides potential for priority review and accelerated approval under 21st Century Cures Act.
Mallinckrodt today announced that StrataGraft regenerative skin tissue is among the first products to be designated as a regenerative medicine advanced therapy by the U.S. FDA under the provisions of the 21st Century Cures Act.
The company's investigational, tissue-based therapy is currently under evaluation in a Phase 3 trial to assess its efficacy and safety in the promotion of autologous skin regeneration of complex skin defects due to thermal burns that contain intact dermal elements (also known as deep partial thickness burns).
