Overview
- The FDA’s January 11 update commits to applying tailored CMC flexibility across clinical development, BLA review, and process validation for cell and gene therapies.
- Manufacturers are not expected to meet 21 CFR part 211 CGMP requirements before producing investigational products for phase 2 or 3 trials.
- INDs may use permissive release acceptance criteria, and minor manufacturing changes can proceed during development when supported by comparability data.
- During BLA review, the agency will consider justified flexibility in commercial release specifications and may later re-evaluate acceptance criteria based on post-approval experience.
- The FDA outlined validation flexibilities, including possible concurrent release and waiving the traditional three PPQ-lot expectation when the proposed lot count is justified by process understanding.