
FDA Unveils Landmark Roadmap to Replace Animal Testing in Preclinical Safety Studies
Key Points: FDA aims to make animal studies the exception rather than the norm within 3–5 years by embracing new approach methodologies (NAMs) based on human biology. Roadmap leverages AI-based computational modelling, human organ-model lab testing and real-world human data. Monoclonal antibodies (mAbs) identified as first priority; animal immunogenicity not
