The FDA issued draft guidance and internal proposals to reduce or eliminate the routine use of nonhuman primate testing for certain monoclonal antibody programs, signaling a policy shift to modernize preclinical requirements. The agency framed the move as an effort to remove unnecessary barriers and align testing with mechanistic risk profiles. Draft documents outline criteria under which sponsors can justify reduced primate studies or rely on alternative in‑vitro and translational approaches. Regulators argued the change could speed early clinical entry, cut costs and reduce animal use without compromising human safety when supported by robust mechanistic data. Industry will evaluate how the guidance affects global development plans, given divergent regulatory expectations across regions. Sponsors noted potential savings and sped timelines but asked for clear implementation details and harmonized expectations from international authorities.