FDA adds flexibility to cell and gene therapies regulation

The US Food and Drug Administration (FDA) has released information on what it calls its flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT).

This more flexible approach has been, and is expected to continue to be, helpful in expediting product development and will help guide the FDA’s evaluation of development strategies in preparation for a Biologics License Application (BLA) submission, the agency says.

FDA commissioner Marty Makary said: “Regulatory flexibility must be tailored for cell and gene therapies.