The US Food Administration (FDA) and the National Institutes of Health (NIH) have announced initiatives to reduce animal drug testing as part of a broader strategy by the Department of Health and Human Services.[1][3] On April 10, 2025, the FDA published a plan to phase out mandatory animal testing, starting with monoclonal antibodies, and encouraging the use of modern methods such as AI models, organoid systems, and chips with human tissues.[2][3] These new approaches can reveal toxic effects specific to humans that cannot be reliably detected by traditional animal tests.[2] The NIH plans to prioritize funding for non-animal research and institute training for grant reviewers to eliminate potential bias against traditional animal models.[3] The FDA also established the ISTAND pilot program and adopted the Emulate Liver-Chip technology to study drug-induced liver injury.[1] The goal is to create a global regulatory environment where animal testing in the development of biological drugs is largely replaced by approved modern methods.[4]