FDA Signals Major Shift Toward Flexible Manufacturing Requirements for Cell and Gene Therapies

January 12, 2026- The U.S. Food and Drug Administration (FDA) has announced plans to reduce regulatory burdens on the manufacturing of cell and gene therapies (CGTs), aiming to accelerate patient access to these advanced treatments.

The agency plans to revise its approach to the chemistry, manufacturing, and controls (CMC) section of marketing applications for CGTs, recognizing that these products are manufactured very differently from traditional pharmaceuticals. Many CGTs are produced in small batches using complex, time-sensitive processes, particularly autologous therapies such as CAR-T treatments that require patient-specific cell collection, modification, expansion, and reinfusion.

The FDA’s Center for Biologics Evaluation and Research (CBER) said it is building on experience gained from reviewing and approving more than 50 CGTs. The goal is to introduce structured regulatory flexibilities within the existing framework that reduce CMC burdens while maintaining rigorous quality and safety standards.

These changes include greater flexibility around manufacturing specifications across clinical development, process validation, and commercial supply stages, including product release criteria. The initiative follows an FDA-hosted roundtable on CGT regulation held last year.

CBER Director Vinay Prasad noted that rapid growth in CGT submissions—many addressing serious or life-threatening conditions—has underscored the need for a more adaptive regulatory approach. FDA Commissioner Marty Makary added that the reforms are intended to reflect the unique characteristics of CGTs and support innovation without compromising quality.

The announcement builds on additional FDA initiatives, including a proposed regulatory pathway for personalized therapies such as gene-editing medicines based on a “plausible mechanism” framework, as well as forthcoming guidance for regenerative medicines and CGTs targeting small patient populations.