Draft guidance issued to reduce animal testing in cancer drug development
FDA proposes streamlined nonclinical safety studies for oncology biologics and conjugated products, aiming to reduce unnecessary animal testing.
What this means
The FDA's draft guidance proposes ways to reduce animal testing for cancer drug development, focusing on biologics and conjugated products by allowing alternative safety assessments. Today's announcement outlines specific recommendations, such as using only one animal species instead of two or replacing certain animal studies with evidence-based methods like weight-of-evidence risk assessments. If finalized, this could speed up cancer drug development while aligning with efforts to minimize animal testing, though the impact will depend on public feedback and final implementation.
From the source
For Immediate Release: May 29, 2026
The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs.
“This draft guidance not only supports the FDA’s commitment to expedite regulatory pathways for meaningful treatments but also fulfills the agency’s promise to reduce the use of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relevant species instead of two, or replacing animal studies with evidence-based approaches — as outlined in this draft guidance — the FDA is advancing a more efficient drug development process.”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This draft guidance, “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products,” is part of the FDA’s broader work to reduce the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.
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.
Related Information
Related Information
• Oncology Center of Excellence Guidance Documents
Media: FDA Request for Comment 202-690-6343
Consumer: 888-INFO-FDA
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Boilerplate
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Reproduced from FDA Press Releases · view original · public domain or open-licensed government work