On January 11, 2026, the FDA issued two news releases putting forward reforms to the chemistry, manufacturing, and control requirements for cell and gene therapy products, one titled FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation and the other titled Flexible Requirements for Cell and Gene Therapies to Advance Innovation. Under the new FDA policy, the agency has loosened certain requirements given the complexity and individualized nature of gene and cell therapies. Some examples of the changes are:
- Clinical Development: As sponsors move from phase 1 to studies designed to establish efficacy for licensure, CBER will allow minor manufacturing changes supported by data showing the comparability of the pre-change and post-change product without expecting overly stringent and onerous comparability data.
- Commercial specifications: CBER will consider submissions seeking to re-evaluate and revise product release acceptance criteria based on post-approval manufacturing experience, when manufacturers demonstrate consistent product quality.
- Process Validation: There is no requirement to supply three (3) PPQ lots for process validation.
According to the FDA, over the last decade, the Center for Biologics Evaluation and Research (CBER) has approved close to 50 cell and gene therapy products. FDA Commissioner Marty Makary described the reforms as “common-sense reforms” to accommodate the unique issues faced by developing cell and gene therapies and is part of the agency’s efforts to “remove barriers and perceived misconceptions that stand in the way of expedited product development.”
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