FDA Loosens CMC Rules to Speed Cell and Gene Therapies

FDA narrows manufacturing oversight for cell and gene therapies, aiming to speed development while keeping patient safety at the center

15 Jan 2026

The change arrived quietly, but its meaning was plain. In January 2026 America’s Food and Drug Administration adjusted how it polices the making of cell and gene therapies. The aim was not to rewrite the rules for all biologics, but to acknowledge a stubborn fact: living medicines are hard to standardise at birth.

For years regulators and developers have been locked in a familiar stand-off. Officials want tight controls and repeatable processes. Biology offers neither, at least early on. Cell and gene therapies often begin with crude methods that evolve as scientists learn how a product behaves in patients. The FDA’s new approach to chemistry, manufacturing and controls accepts that messiness. It shifts attention towards understanding the product and protecting patients, rather than freezing production methods too soon.

The industry has been asking for such leniency. Advanced therapies now dominate some of the richest drug pipelines. Speed matters, and manufacturing requirements have often slowed trials as firms scrambled to meet expectations designed for more predictable drugs. Allowing processes to mature alongside clinical data could ease a long-standing bottleneck.

“This approach better aligns regulatory oversight with the science behind these therapies,” said Marty Makary, the FDA’s commissioner, when announcing the policy. He was careful to add that flexibility does not imply lower standards.

The timing is helpful. Big firms such as Moderna and AstraZeneca are investing heavily in platforms for advanced therapies. Contract manufacturers, too, are adding capacity in anticipation of demand. Clearer, more forgiving expectations may prompt companies to scale earlier and put more money into American plants, rather than waiting for certainty that never quite arrives.

Yet looseness has its risks. Developers must still show that they can control quality and deliver consistent products. If the new rules are applied unevenly, they could create fresh uncertainty. The FDA says it will lean on earlier and more frequent talks with sponsors to keep surprises to a minimum.

Taken together, the change is modest but telling. It is a small step towards modernising regulation for a field driven by rapid science and tight clocks. By bending without breaking, the FDA hopes to help the next generation of living drugs reach patients faster and more safely.