Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products Draft Guidance May 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-pharmaceuticals-streamlined-nonclinical-safety-studies-biologics-and-conjugated-products?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs. “This draft guidance not only supports the FDA’s commitment to expedite regulatory pathways for meaningful treatments but also fulfills the agency’s promise to reduce the use of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 FDA’s Oncology Center of Excellence Director Angelo de Claro, M.D. “With recommendations for eliminating unnecessary animal testing, using a single relevant species instead of two, or replacing animal studies with evidence-based approaches — as outlined in this draft guidance — the FDA is advancing a more efficient drug development process.” When finalized, the guidance will provide recommendations for general toxicology studies, including when animal testing may be unnecessary because there is no binding or pharmacologic activity. In some cases, the guidance recommends using rodent studies only or replacing three-month non-human primate studies with a weight-of-evidence risk assessment. That assessment may include New Approach Methodologies, as appropriate. New Approach Methodologies were defined in a recent FDA webpage. This draft guidance, “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products,” is part of the FDA’s broader work to reduce the estimated 10 to 12 years it can take to bring new drugs from discovery to patients. It builds on FDA data analysis of general toxicology studies and practices developed during the COVID-19 pandemic to reduce the use of non-human primates. It also supplements guidance issued by the International Council for Harmonisation (ICH) and FDA guidance on nonclinical studies for oncology therapeutic radiopharmaceuticals. https://www.fda.gov/science-research/science-and-research-special-topics/new-approach-methodologies-nams?utm_medium=email&utm_source=govdelivery The FDA requests that public comments on the draft guidance be submitted by July 30, 2026. The agency will review and consider comments received before finalizing the guidance. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-therapeutic-radiopharmaceuticals-nonclinical-studies-and-labeling-recommendations-guidance?utm_medium=email&utm_source=govdelivery