The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) issued guidance detailing steps to offer greater regulatory flexibility on chemistry, manufacturing and control (CMC) requirements for cell and gene therapies. The agency framed the move as drawing on growing experience with these modalities to speed development without compromising product quality. FDA said the approach will allow case‑by‑case adaptations in testing and release strategies and encouraged early engagement between sponsors and regulators. The guidance aims to reduce development bottlenecks specific to complex biologics manufacturing and to support more streamlined paths to clinic while retaining standards for safety and consistency.