FDA's Manufacturing Registration Rule's Impact on Advanced Therapies: Part 2

On July 10, 2026, the FDA proposed a rule that would let distributed "hub-and-spoke" manufacturing networks register as a single establishment rather than site by site, while still requiring centralized quality oversight.¹ Jason Bock, founder and CEO of CTMC, a joint venture with MD Anderson, says earning that trust requires the industry to move away from site-by-site manufacturing and toward a fully digital quality system, where every site runs off identical batch records and standard operating procedures. Without that, version control drifts between locations. An integrated system also allows a deviation or corrective and preventive action at one site to be pushed immediately to another site so the same mistake isn't repeated. For advanced therapies, where each batch is an individualized dose for an individualized patient, a lost batch isn't just an inventory hit; it can mean a patient doesn't get treated.

The proposed rule also closes a registration gap for foreign API and intermediate suppliers, but Bock notes this mainly affects small-molecule supply chains. Advanced therapies depend on viral vectors, specialized reagents, and single-use disposables from a concentrated supplier base, and Bock argues that robustness is currently something industry must build itself rather than something the rule directly addresses—though FDA attention may grow as these therapies scale. Bock sees the rule as part of a broader, encouraging trend of the FDA using data to reduce regulatory friction for advanced therapies. These regulatory actions signal genuine alignment between industry and the FDA on accelerating advanced therapies.

“I think we really feel in industry that we now have a partner with FDA about how to develop these amazingly impactful therapies in concert with FDA, to bring them to more patients and to have the full potential that they can have,” Bock states.

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Click here to watch part 1 of the interview.