FDA Modernization Act 3.0

Summary

FDA Modernization Act 3.0 This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug.  The rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications.  The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule. 

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Documents

4 official files

• Engrossed in House

  Engrossed in House · EN · 20 July 2026

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• Reported in House

  Reported in House · EN · 18 June 2026

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• Introduced in House

  Introduced in House · EN · 10 April 2025

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• Introduced in House

  summary · EN · 10 April 2025

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