FDA Modernization Act 3.0: What It Means for NAMs

FDA, NIH, and EMA All Moved on Non-Animal Testing in September 2026

In This Article
FDA's Draft Guidance on New Approach Methodologies
FDA's Draft Guidance on March, 2026. Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-considerations-use-new-approach-methodologies-drug-development
Organoids function as New Approach Methodologies (NAMs).
Liver Organoid: mirror the cellular diversity and metabolic functions of human liver tissue.

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