Oversight of Regenerative Medicine: FDA’s new regulatory approach
Regenerative medicine—a field that includes stem cells, bioengineered tissues, and gene therapies—holds great potential. In November 2017, the Food and Drug Administration updated its regulatory framework for these products. Peter Marks, who leads the agency’s Center for Biologics Evaluation and Research (CBER), about the framework gave this interview. Q: What led FDA to update its regulatory framework