The FDA updated policies to allow regenerative medicine advanced therapy (RMAT) designations for candidates even if programs are on clinical hold, a procedural change that can preserve regulatory incentives for smaller cell and gene therapy developers. Separately, the agency released draft guidance encouraging validated alternative approaches to toxicology and early‑phase safety testing that could reduce reliance on animal studies. Together these moves reflect regulatory flexibility aimed at accelerating advanced therapies and lowering preclinical barriers while preserving safety review standards.