A decade in the making: How functional NAMs are redefining cardiac safety assessment

Is the shift to NAMs sudden? Explore the decade-long journey of New Approach Methodologies, from the FDA's ISTAND program to the latest standards in cardiac safety workflows. When the FDA Modernization Act 2.0 was signed into law in 2022, it was widely interpreted as a turning point for New Approach Methodologies (NAMs). By removing the statutory requirement for animal testing and explicitly allowing non-animal methods, the legislation appeared to signal a sudden regulatory embrace of alternative approaches. In reality, this moment has been more than a decade in the making. The Act recognized that the scientific, technical, and regulatory groundwork…

In recent years, the momentum behind New Approach Methodologies (NAMs) in drug safety testing has accelerated rapidly. Driven by regulatory initiatives, evolving guidance, and growing internal pressure within pharmaceutical organizations, this acceleration can make it feel as though NAM adoption has arrived suddenly, almost overnight. When the FDA Modernization Act 2.0 was signed into law…

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