Comment from American College of Laboratory Animal Medicine

The American College of Laboratory Animal Medicine (ACLAM) respectfully submits these comments in response to the U.S. Food and Drug Administration’s (FDA) draft guidance entitled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products,” published in May 2026. ACLAM is a not-for-profit specialty board recognized by the American Veterinary Medical Association. Through certification of veterinary specialists, professional development, education, and research, ACLAM promotes the humane care and responsible use of laboratory animals. ACLAM strongly supports the Agency’s objective of modernizing nonclinical safety evaluation and advancing the principles of Replacement, Reduction, and Refinement (the 3Rs).