The FDA released draft guidance recommending ways to reduce or avoid nonhuman primate testing for certain monoclonal antibodies, signaling a regulatory shift aimed at modernizing preclinical safety assessment. Agency documents and subsequent reporting outlined scenarios where alternative in vitro or in silico approaches may suffice for human risk assessment. The guidance is part of broader FDA efforts to streamline development, lower costs, and align with evolving scientific practices. Industry groups and companies will now weigh the operational impact and implementation timelines as the agency moves through consultation and finalization steps.