Humane World for Animals and Humane World Action Fund encouraged by newly proposed guidance to advance non-animal methods

WASHINGTON (March 18, 2026)—The U.S. Food and Drug Administration (FDA) has made further progress toward replacing animal use in testing with suitable non-animal methods. Humane World for Animals and Humane World Action Fund, formerly called the Humane Society of the United States and Humane Society Legislative Fund, today welcome newly proposed FDA guidance that encourages pharmaceutical companies seeking regulatory approval to submit data from non-animal methods, providing a framework for validation considerations of these methods.

“We are pleased to see FDA release draft guidance specifically focused on new approach methods, as we’ve been pressing for,” said Kathleen Conlee, vice president for animal research issues at Humane World for Animals. “While this is a positive step, we will be urging the agency to further strengthen and broaden their proposal while also calling on industry to work with FDA to advance non-animal methods to reduce animal suffering and promote scientific innovation.”

Human-relevant, non-animal methods such as advanced cell-based systems using human cells can provide more accurate and efficient insights into how drugs affect people than animal tests can provide.

This is the latest in a series of steps the agency has taken over the past two years to reduce reliance on animal testing. In May 2024, Humane World for Animals submitted a legal petition to accelerate the adoption of non-animal methods, which included specific recommendations on how to do so.

In April 2025, the FDA released a roadmap outlining its plan to make animal experiments the exception rather than the rule in drug evaluations, incorporating several of the reforms outlined in the petition. Since then, the agency has begun implementing that roadmap, by identifying unnecessary animal tests that can be reduced or eliminated and updating its website to highlight instances when accepted non-animal methods could be used in drug development.

“The FDA is continuing its drum beat of announcements moving away from outdated animal methodologies with the release of this guidance, which encourages the industry to submit data from non-animal approaches instead of animal testing data,” said Tracie Letterman, vice president for federal affairs at Humane World Action Fund. “We’re encouraged by the Trump administration’s stated commitment across the federal government to make animal testing a matter of last resort, however, if FDA really wants the industry to submit data from non-animal methods, the next step is for FDA to revise its regulations to make it clear that animal testing is not legally required for drug approvals.”

Today’s action follows a series of announcements made by federal agencies since last year to reduce reliance on animal testing. This includes the Environmental Protection Agency’s renewed commitment to eliminate tests on dogs, rabbits and other mammals by 2035, FDA’s introduction of new draft guidance to reduce testing of monoclonal antibodies using non-human primates such as monkeys, and the National Institutes of Health‘s stated plan to prioritize human-based research technologies to reduce animal experiments in NIH-funded research.

NIH also announced today that it is investing $150 million in human-based research to reduce use of animals, through its first ever awards under the Complement Animal Research in Experimentation (Complement-ARIE) program. These “Technology Development Centers” will develop non-animal platforms to cover diverse topics including better understanding of women’s health, disease pathologies, neurodevelopmental issues and chemical safety screening.

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