US FDA increases flexibility on CMC rules for cell and gene therapies

The US Food and Drug Administration (FDA; MD, USA) has provided information about some of the changes in the chemistry, manufacturing and control (CMC) requirements that apply to cell and gene therapies. In June 2025, the FDA hosted a Cell and Gene Therapy Roundtable, which brought together leading experts to discuss the field of cell and gene therapies. This roundtable, which is available to watch on demand, aimed to create a space where experts and the FDA could have a transparent conversation about innovation, collaboration and regulatory and commercial challenges that continue to limit patient access. Gold-standard science and common sense:...