FDA and NIH Take Actions to Reduce Reliance on Animal Testing with New Draft Guidance and Funding Announcement

March 20, 2026Policy & Regulation, Food and Drug Administration (FDA), Life Sciences, FDA Enforcement

On March 18, 2026, the Food and Drug Administration (FDA) issued draft guidance entitled “General Considerations for the Use of New Approach Methodologies in Drug Development.” The guidance is meant to provide drug developers with a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development. The use of NAMs can improve predictive toxicology in humans and reduce reliance on animal testing.

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