This week, the US Senate unanimously passed the FDA Modernization Act 3.0, reinforcing a clear shift toward more predictive, human-based approaches in drug development.

The legislation directs the FDA to update language that mandated animal testing, replacing it with broader “nonclinical” terminology. This change creates regulatory space for advanced methods that better reflect human biology, such as iPSC-derived models, organoids, MPS, and, importantly, computational models.

It has been nearly three years since Congress eliminated the legal requirement that animal testing be conducted as part of the new drug development process, and since then, the FDA has taken meaningful steps to modernize nonclinical drug evaluation. The FDA Modernization Act 3.0 will help lock in these reforms, ensuring that FDA regulations mirror current law and reflect the best available science, supporting the agency’s transition toward more predictive, humane research tools. This is how we improve public health and follow the science, all while reducing unnecessary animal suffering,” said Senator Cory Booker.

The FDA roadmap already prioritizes New Approach Methodologies (NAMs), including advanced in vitro systems and computational models. This legislation reinforces that directive.

Federal agencies are already moving in this direction. The NIH is expanding investment in organoid and tissue-chip technologies, and the CDC has announced plans to phase out non-human primate testing.

Axol Bioscience is committed to closing the translational gap and developing physiologically relevant iPSC-derived disease models that improve consistency and relevance in human disease modeling and compound testing.

Read the official press release: https://centerforahumaneeconomy.org/senate-passes-fda-modernization-act-3-0-by-unanimous-consent/

Get in contact with us: https://axolbio.com/contact-us/