The U.S. Food and Drug Administration (FDA) issued a new draft guidance aimed at reducing unnecessary animal testing in nonclinical safety assessments for certain oncology treatments. The document, titled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products,” marks a significant step forward in the agency’s commitment to advancing humane, efficient science.
Key recommendations include eliminating animal testing entirely when there is no binding or pharmacologic activity, utilizing a single relevant animal species instead of two, and replacing certain three-month non-human primate studies with a comprehensive “weight-of-evidence” risk assessment. This risk assessment may incorporate New Approach Methodologies (NAMs), which are modern, non-animal testing alternatives.
“This draft guidance not only supports the FDA’s commitment to expedite regulatory pathways for meaningful treatments but also fulfills the agency’s promise to reduce the use of animal testing during drug development,” said Angelo de Claro, M.D., Director of the FDA’s Oncology Center of Excellence.
The initiative builds on FDA data analysis and conservation practices developed during the COVID-19 pandemic. By modernizing these safety assessments, the FDA aims to shorten the traditional 10-to-12-year timeline required to bring new therapeutics to patients.
The FDA requests public comments on the draft guidance by July 30, 2026, before finalizing the document.
Written by: Pragna Biswas
Graphics by : Pramit Hazra
