The FDA announced it will consider regenerative medicine advanced therapy (RMAT) designations for candidate cell and gene therapies even when those programs are under clinical hold. The procedural change aims to give smaller developers greater access to regulatory incentives while their safety or manufacturing issues are being resolved. Agency officials framed the move as supportive of innovation in regenerative medicine, potentially preserving expedited development pathways for programs that can address the reasons behind holds. The change may affect biotech companies balancing early‑stage manufacturing challenges and clinical safety signals while pursuing accelerated regulatory designations.