The U.S. Food and Drug Administration released draft recommendations that in some cases allow biopharma companies to reduce or eliminate testing monoclonal antibodies in nonhuman primates before first‑in‑human studies. The guidance outlines alternative safety strategies and data packages that could replace routine primate work for certain antibody programs. The move responds to scientific advances and international pressure to limit primate use, and it aims to accelerate development while maintaining patient safety. Agency documents frame the change as both a science‑driven and efficiency measure, especially for antibody formats with well‑characterized biology. Biotech and CROs will need to adapt development plans, toxicology strategies and regulatory submissions; firms with non‑primate safety platforms could gain an advantage in speed and cost of entry to clinical testing.