FDA updates regulations to support alternatives to animal testing

21st September 2026

Summary: The FDA has issued a direct final rule clarifying that non-animal testing methods may be used, where appropriate, to evaluate the safety of drugs and biological products before human trials. The changes recognise advances in technologies such as human cell-based systems, organ-on-a-chip models and computational approaches. The regulatory update is intended to support innovation in preclinical research while maintaining existing safety standards. The development is particularly relevant to organisations involved in non-clinical safety assessment, regulatory toxicology and the implementation of New Approach Methodologies (NAMs).

Link: https://www.fda.gov/news-events/press-announcements/fda-updates-regulations-advance-innovative-alternatives-animal-testing

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