The FDA released draft recommendations aimed at reducing or eliminating the use of nonhuman primates for certain monoclonal antibody safety testing. The agency’s plan outlines circumstances where alternative in vitro and non-primate in vivo approaches can replace traditional monkey studies, signaling a regulatory shift to modernize preclinical pathways for biologics. The guidance is intended to accelerate development timelines and reduce costs for antibody developers while maintaining safety standards. Companies developing mAbs will need to assess applicability case-by-case and engage early with agency reviewers. The draft also reflects broader policy moves to streamline preclinical packages amid competitive global biologics development.