CGT Regulation In 2026 Moves Toward Disciplined Flexibility And Higher Standards

This first segment of Cell & Gene Live, “2026 Regulatory Roadmap,” Cell & Gene's Chief Editor and Wilson Bryan, M.D., former director of FDA’s Office of Tissues and Advanced Therapies (OTAT) and Daniela Drago, Ph.D., RAC, Partner at NDA Partners highlighted that CGT regulation in 2026 has entered a more mature phase, with increased approvals, higher regulatory scrutiny, and a shift from broad flexibility toward “disciplined flexibility” that depends on strong CMC, clinical, and risk-based foundations. As larger, more experienced sponsors enter the field and FDA leadership evolves, regulators are maintaining high evidentiary standards while offering conditional flexibility. They are placing greater responsibility on sponsors to demonstrate robust process control, clear benefit–risk understanding, and well-justified development strategies.