Gottlieb: Gene Therapies Eligible For Cures-Created Designation, FDA Stepping Up Enforcement

FDA Commissioner Scott Gottlieb said Monday (Aug. 28) that certain gene therapy products will be eligible for a 21st Century Cures-created expedited pathway for regenerative medicine products. Gottlieb also doubled down on his earlier promise to develop a framework for regenerative medicine by this fall and put industry on notice that FDA will step up enforcement against unapproved regenerative medicine treatments. The agency has yet to approve a gene therapy, which are treatments that deactivate or replace the genes that...