Animal testing reforms are gaining momentum, but technology can't yet replace all uses.

The FDA released draft guidance encouraging New Approach Methodologies and the NIH announced $150 million to develop animal-testing alternatives; experts say current technologies cannot yet answer all research questions.

The FDA this week posted an image highlighting research monkeys and released draft guidance aimed at clarifying how drug developers can use nonanimal approaches when seeking approvals. The National Institutes of Health announced a $150 million investment to develop alternatives and said it will create seven technology development centers. The shift follows the 2022 FDA Modernization Act 2.0, which removed a previous mandate requiring animal studies for some therapies. Researchers and advocates say new tools are promising but cannot yet replace all animal studies. Key points: - The FDA's draft guidance encourages the use of New Approach Methodologies (NAMs) and aims to guide sponsors on alternative testing when seeking approvals. - The NIH announced $150 million for development of animal-model alternatives and plans seven technology development centers to support new approaches and data sharing. - HHS Secretary Robert F. Kennedy Jr. is quoted as supporting a move toward human-relevant methods; the guidance is not final. - Data show more than 3.18 million animals were used in USDA-licensed research facilities in the past four years; experts say that excluding common laboratory species could add an estimated 111 million more animals to the total. - Alternative methods cited include organs-on-a-chip, organoids, reconstructed human tissues, and computer simulation models, but each has limits such as inability to capture whole-body interactions, immune or endocrine responses, long-term effects, or the large datasets needed for reliable algorithms. Summary: Federal actions from the FDA and NIH signal a policy shift toward reducing reliance on animal testing and promoting new technologies, but experts and researchers note that current nonanimal methods do not yet address many integrated-system questions and that animal research will continue in the near term. Undetermined at this time.