The FDA issued draft recommendations and discussion documents indicating it will reduce or remove the routine requirement for nonhuman primate testing in some monoclonal antibody development programs. The agency released guidance and meeting summaries outlining criteria for alternative approaches and when primate studies may still be necessary. The draft guidance aims to align toxicology testing with scientific advances and reduce reliance on scarce primate resources, potentially accelerating early clinical translation for certain biologics while changing non‑clinical development planning and costs for sponsors. Monkey toxicology studies (NHPs) have historically been used for cross‑reactive mAb safety evaluation; the guidance clarifies acceptable non‑primate alternatives in defined cases.