The FDA has announced a more flexible approach to overseeing the chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT). This approach accelerates product development and helps prepare for a Biologics License Application (BLA).[1] Over the past decade, the Center for Biologics Evaluation and Research (CBER) has approved nearly 50 CGTs.[1] FDA Commissioner Marty Makary has stated that regulatory flexibility must be tailored to the specific characteristics of cell and gene therapies.[1] Vinay Prasad, CBER's chief medical and scientific officer, noted the explosive growth in CGT submissions targeting serious or life-threatening conditions with unmet need.[1] Vijay Kumar, interim director of the Office of Therapeutic Products at CBER, emphasized that FDA is communicating flexibility that was previously applied on a case-by-case basis to accelerate development across the CGT sector.[1] The flexibility applies to all sponsors regardless of the review team at CBER.[1]