The FDA announced it will consider regenerative medicine advanced therapy (RMAT) designations even for experimental therapies placed on clinical hold, revising prior practice. The policy shift was framed as a measure to help smaller cell‑ and gene‑therapy companies retain expedited regulatory support while addressing safety signals. Industry observers noted the change could preserve access to RMAT benefits—priority review and more regulatory engagement—for programs that pause for manufacturing or safety investigations, potentially reducing development disruption for early‑stage developers.