FDA Announces Flexible Manufacturing Approach for Cell and Gene Therapies on January 11, 2026
The FDA announced on January 11, 2026, a more flexible approach to chemistry, manufacturing, and control (CMC) requirements for cell and gene therapies (CGT) to expedite development and innovation while maintaining quality standards.234
Flexibilities include looser quality controls in later clinical trials, minor manufacturing changes between Phase I and II with data support, and flexible post-approval specifications for Biologics License Applications (BLAs).235
The agency dropped the requirement for three rounds of Process Performance Qualification (PPQ) before commercial production in certain cases, allowing batch-by-batch design.2
FDA Commissioner Marty Makary described the reforms as 'common-sense' to address CGT's unique characteristics and foster innovation.246
Vinay Prasad, Director of CBER, noted explosive growth in CGT submissions for serious conditions with unmet needs.24
These changes build on prior initiatives like the 'plausible mechanism pathway' from November 2025.26
Sources:
2. https://www.clinicaltrialsarena.com/news/fda-increases-manufacturing-flexibility-for-cell-and-gene-therapies-2/
3. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/flexible-requirements-cell-and-gene-therapies-advance-innovation
4. https://www.fda.gov/news-events/press-announcements/fda-increases-flexibility-requirements-cell-and-gene-therapies-advance-innovation
5. https://xtalks.com/fda-clarifies-cmc-flexibility-for-cell-and-gene-therapies-4582/
6. https://www.biospace.com/fda/fda-carves-out-manufacturing-exemptions-for-cgts-to-accelerate-development