US FDA proposes using existing science to speed up gene therapy development

FDA proposes letting makers of cell and gene therapies for rare, life‑threatening diseases use existing scientific, manufacturing and clinical knowledge from similar products to speed development.
Agency says leveraging that prior knowledge could streamline submissions and reviews and help accelerate personalized treatments when traditional trials aren’t feasible.
The move comes amid recent scrutiny of FDA rare‑disease decisions and the resignation of Commissioner Marty Makary; the agency is now led by acting Deputy Commissioner Kyle Diamantas.