The FDA’s Center for Biologics Evaluation and Research announced steps to modernize and provide more flexible chemical, manufacturing and control (CMC) expectations for cell and gene therapies, moving away from a one‑size‑fits‑all approach. The guidance clarifies use of risk‑based CMC data packages and alternative comparability strategies for platform and individualized products, reflecting CBER’s accumulation of real‑world experience with CGTs. Regulators framed the shift as intended to expedite development while maintaining product safety and quality, and the decision is likely to affect sponsors’ development timelines, CMC budgets and manufacturing strategy for both autologous and allogeneic programs.