FDA introduces flexible regulations to accelerate cell and gene therapies

The U.S. Food and Drug Administration (FDA) is now providing clear details about their flexible requirements for cell and gene therapies (CGT), according to an announcement.

Furthermore, the Center for Biologics Evaluation and Research (CBER) has applied additional FDA-approved regulatory flexibilities to “accommodate the unique characteristics of these innovative therapies, while maintaining rigorous quality standards through appropriate control measures.”

The process aims to accelerate the time it takes to develop CGTs and “will help guide the FDA’s evaluation of development strategies in preparation for a Biologics License Application (BLA) submission.” 50 CGTs have been approved by the CBER over the last ten years, according to the FDA.