FDA to Alter Oversight of Stem Cell Products From University Labs

The FDA wants to exercise new regulatory authority over academic physicians developing stem cells and other new regenerative medicine products in their laboratories.

The new oversight program, which Food and Drug Administration Commissioner Scott Gottlieb said Nov. 15 could come out as early as this week, is part of a larger plan Gottlieb announced in the summer to develop a regulatory framework for regenerative medicine. The plan also falls in line with other agency initiatives to offer new regulatory models that account for rapidly emerging technologies.

“Regenerative medicine is a very rapidly evolving field,” Gottlieb said.

Regenerative medicine, the ...