The U.S. Food and Drug Administration outlined steps to relax and modernize manufacturing and quality expectations for cell and gene therapies, signaling increased regulatory flexibility to accelerate clinical development. CBER described targeted accommodations in chemistry, manufacturing and control (CMC) requirements that leverage program‑specific risk assessments rather than a one‑size‑fits‑all standard. The agency’s guidance aims to reduce barriers that have slowed CGT programs while maintaining product quality and patient safety. Industry presentations at JP Morgan and subsequent reporting described the move as a formalization of incremental FDA flexibility that sponsors have been seeking. Sponsors and CDMOs are expected to respond by adapting process development strategies to the risk‑based framework, potentially shortening timelines for INDs and early‑phase studies while encouraging innovation in manufacturing platforms.