This podcast, a roadmap from the FDA, features a strategy to decrease animal testing in preclinical safety studies by increasing the use of New Approach Methodologies (NAMs) like organ-on-a-chip systems and computer modeling. The roadmap acknowledges the limitations of animal models in predicting human responses and highlights scientific, ethical, and economic drivers for this shift. It proposes a phased implementation, starting with monoclonal antibodies, and emphasizes interagency collaboration, particularly through ICCVAM, to validate and adopt these novel methods. The FDA aims to develop clear regulatory guidance, incentivize the use of NAMs, and establish a long-term vision where animal testing becomes the exception rather than the rule, ultimately improving drug development and public health. Produced by Dr. Jake Chen.