The FDA unveiled plans and draft guidance aimed at reducing or eliminating the need for primate testing in certain monoclonal antibody development programs. Agency documents propose alternative nonclinical strategies in select cases to encourage more U.S.-based innovation and reduce reliance on costly and ethically fraught primate studies. Regulators argued the change reflects advances in in vitro and computational safety assessment and will align nonclinical packages with current scientific capabilities. Industry groups and sponsors are evaluating operational and regulatory implications; sponsors may be able to streamline IND-enabling packages, shorten timelines, and lower costs if the guidance is finalized and adopted.