STAT+: HHS unveils new initiatives to reduce animal testing in drug development — SkimNews
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- HHS announced new strategies — the second set this year — to accelerate the shift toward human-based research methods and reduce animal use in medical testing.
- FDA issued a final rule stating that non-animal research methods can be used when "appropriate" for determining the safety of drugs and biologics.
- The FDA rule changes longstanding terminology, replacing "animal tests" and "animal studies" with "nonclinical tests" and "nonclinical studies" across its framework.
- NIH unveiled several initiatives, including $88 million in funding for 10 infrastructure projects nationwide designed to encourage "new approach methodologies."
- The NIH-funded projects will support alternatives such as cell-based assays, organs-on-a-chip, and computer models.
Why it matters: Drug developers now have a finalized FDA pathway to use non-animal safety testing where appropriate, alongside $88 million in NIH infrastructure for alternatives like organs-on-a-chip. The FDA's rewording of longstanding statutory language signals regulatory legitimacy for methods that were previously the exception rather than the rule.
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