The FDA and NIH are following through on commitments made in 2025 to begin phasing out cruel animal tests by revealing major initiatives toward that goal.

On March 18, 2026 the two agencies announced that they are putting significant resources and regulatory weight behind non-animal methods, or what the industry refers to as New Approach Methodologies (NAMs).

The FDA has released draft guidance supporting the use of animal -free methods like organoids, organs-on-chips and computational models to promote their use in drug development over standard animal tests.

Streamlining the Path to Validation

Crucially, the FDA signaled increased flexibility by allowing drug companies to submit non-animal data even if the methods are not yet fully validated, provided they demonstrate relevance for regulatory decision-making. For years, the onerous process of validating non-animal methods was a bottleneck, but the FDA is now implementing a more flexible, ongoing framework by encouraging a "fit-for-purpose" approach. This allows drug developers to utilize these non-animal methos immediately, rather than being required to complete a years-long formal "qualification" process.

The $150 Million Investment in Human Biology

The NIH is backing this shift with serious funding, announcing $150 million for the Complement Animal Research in Experimentation program to develop and standardize animal alternatives. This significant investment is in addition to $87 million allotted last year to establish the Standardized Organoid Modeling Center. NIH will also use the funding to establish specialized technology development centers to promote the use of NAMs in the areas of greatest scientific and regulatory need.

A Decade of Relentless Advocacy

This progress is powerful validation of the mission CAARE has championed since our founding in 2014. From day one, we have been laser-focused on the message that modern technology has the capacity to replace animals with human-relevant science to advance medicine and spare animals.

We’re winning—but we can't stop now. 

We’re still far from a world without animal experiments but this is a significant step towards ending animal research. This historic shift wouldn’t be happening without years of dedicated efforts. Together we will keep the pressure on and hold these agencies accountable to their promises to phase out animal labs.

Citizens for Alternatives to Animal Research and Experimentation (CAARE), is a 501(c)(3) non-profit organization, established to highlight and promote research without animals. Please donate to support CAARE’s mission to reduce animal suffering by disseminating information about the power and progress of research without animals. 

We gratefully accept gifts from Donor Advised Funds. Our legal name is Citizens for Alternatives to Animal Research and Experimentation, EIN: 46-5261800, P.O. Box 102, Ardsley, NY 10502.