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Tuesday, December 17, 2024

Senate passes bipartisan bill to modernize FDA regulations

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Senator Eric Schmitt | U.S. Senator Eric Schmitt

Senator Eric Schmitt | U.S. Senator Eric Schmitt

The United States Senate has passed the FDA Modernization Act 3.0, a bill introduced by Senator Eric Schmitt and Senator Booker. This legislation aims to reduce unnecessary animal testing while promoting scientific innovation in drug development.

The act builds on previous efforts, notably FDAMA 2.0, signed into law by President Biden in 2022. The earlier version removed the requirement for investigational new drugs to undergo mandatory animal testing before human clinical trials, allowing drug developers to use advanced non-animal methods such as cell-based assays, organ chips, computer modeling, and bioprinting.

Despite these changes, the FDA has not yet updated its regulations to align with FDAMA 2.0. The newly passed FDA Modernization Act 3.0 mandates that the FDA update its regulations within six months of the bill's enactment. Additionally, it addresses a technical correction related to a duplicated section heading in the statute.

The bipartisan effort behind this legislation seeks to make drug development more humane and efficient, ultimately providing faster and more reliable treatments for patients.

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