FDA Announces More Flexible Approach to CGT Regulation

The Food and Drug Administration outlined a more flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT) as the agency looks to expedite development of these products.

In a Sunday news release, FDA stated that the Center for Biologics Evaluation and Research has leveraged its experience with CGTs to identify and implement regulatory flexibilities allowed under FDA’s regulations “that accommodate the unique characteristics of these innovative therapies while maintaining rigorous quality standards through appropriate control measures.” 

Previously, these flexibilities, which cover areas such as clinical development, commercial specifications and process validation, were applied on a case-by-case basis to select CGT therapies.

FDA said it is proactively communicating these approaches to help ensure sponsors and other stakeholders understand what types of regulatory flexibility may be scientifically acceptable as they prepare development strategies and biologics license application (BLA) submissions.