The US Food and Drug Administration has issued a draft guidance to reduce animal testing in non-clinical safety assessments for certain cancer drugs.

“This draft guidance not only supports the FDA’s commitment to expedite regulatory pathways for meaningful treatments but also fulfils the agency’s promise to reduce the use of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.“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relevant species instead of two, or replacing animal studies with evidence-based approaches — as outlined in this draft guidance — the FDA is advancing a more efficient drug development process.”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 finalised, 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. The FDA has called for public comments on the draft guidance by July 30.

Published on June 1, 2026