Decoding FDA’s new flexible CMC requirements for cell and gene therapies

On January 11, 2026, the FDA announced information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGTs).1  

While highlighting the agency’s initiatives to facilitate the development of CGTs, the FDA announcement does require some clarifications and context for CGTs sponsors to understand how to implement the flexibilities into their development programs.  

Here we discuss some of the critical points covered in the announcement and provide our insights:

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