The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT).
FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation
FDA announces a more flexible approach to chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGTs) to speed development while maintaining safety, purity and potency. CBER has historically applied similar flexibilities but will now communicate these approaches more broadly to guide sponsors and reviewers toward scientifically acceptable, flexible CMC practices. The changes…
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