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Vanda Pharmaceuticals Calls for Stronger FDA Action to Accelerate Shift From Animal Testing to Human-Relevant Methods
The FDA's draft guidance supports validation of human-centric new approach methodologies to improve drug safety predictions and reduce animal testing, with $150 million NIH investment.
- On Friday, March 20, 2026, the FDA released draft guidance urging pharmaceutical companies to accelerate the transition from animal testing to 'new approach methodologies' in drug development.
- This guidance represents the latest stage in the FDA's roadmap for reducing animal testing, published in April last year, following earlier measures limiting toxicity studies of monoclonal antibody-based drugs in non-human primates.
- "Technological advances are allowing us to move beyond animal testing," said FDA Commissioner Marty Makary, noting the guidance supports organ-on-chip devices, organoids, and computer modeling techniques that better reflect human biology.
- Simultaneously, the NIH announced it will invest $150 million in human-based research to develop tools for reducing animal models, marking the first awards under the Complement Animal Research in Experimentation programme.
- The draft guidance remains open for comment until 18th May. Vanda Pharmaceuticals Inc. called for the FDA to incorporate more robust citations and concrete examples of validated NAMs to ensure clearer regulatory criteria.
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The Courier-Tribune+26 Reposted by 26 other sources
Vanda Pharmaceuticals Calls for Stronger FDA Action to Accelerate Shift from Animal Testing to Human-Relevant Methods
WASHINGTON, March 19, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), a leader in innovative drug development and a vocal advocate for reducing unnecessary animal testing, today voiced serious concerns over the U.S. Food and Drug Administration (FDA)'s new…
FDA outlines plan to phase out animal testing in new draft guidance
The FDA's guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM approach.The post FDA outlines plan to phase out animal testing in new draft guidance appeared first on Clinical Trials Arena.
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Leaning Left4Leaning Right4Center9Last UpdatedBias Distribution53% Center
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53% Center
L 24%
C 53%
R 23%
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