The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) published guidance outlining relaxed chemical, manufacturing and control (CMC) expectations for certain cell and gene therapies. The agency said it will apply experience‑based flexibility to accommodate diverse CGT modalities and expedite development while maintaining product quality. FDA communications framed the move as a modernization effort to avoid a one‑size‑fits‑all approach; the guidance clarifies when and how sponsors can propose alternative analytical strategies, comparability plans, and post‑approval commitments. The agency stressed that flexibility depends on robust justification and risk‑based controls. Who’s involved: U.S. FDA (CBER); guidance released Jan. 11 and covered in regulatory roundups. Sponsors developing CGTs should engage early with FDA on tailored CMC plans and comparability strategies to leverage the new flexibility.