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News in English (USA) / 12.01.2026 / 15:00

FDA Enhances Flexibility for Cell and Gene Therapies

The FDA has announced a series of measures to increase flexibility in the manufacturing and development of cell and gene therapies (CGTs). This initiative aims to advance innovation by easing Chemistry, Manufacturing, and Controls (CMC) rules and carving out manufacturing exemptions for CGTs. Nearly 50 therapies stand to benefit from this new approach, which is designed to remove barriers and accelerate the development process in this rapidly evolving field.
fda.gov, Yahoo, BioSpace, FirstWord, geneonline.com, Pharmaphorum, Pharmaceutical Technology