Excitement and wariness as FDA shifts to much more flexible cell and gene therapy oversight The new system is a big regulatory experiment with many tradeoffs

https://www.statnews.com/2026/01/20/fda-cell-gene-therapy-cgt-oversight-flexible-system-risks/ By Paul KnoepflerJan. 20, 2026 Knoepfler is a professor of cell biology and human anatomy at UC Davis School of Medicine.