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S. 355 · 119th Congress

FDA Modernization Act 3.0

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IntroducedPassed one chamberPassed both chambersBecame law (gold)Resolution agreed to (full, dark)Failed or vetoed (gray)

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Passed the Senate without a recorded vote. It passed by voice vote or unanimous consent, which don't record how each member voted. Its text can still change before it becomes law.

9 cosponsors · 4 D, 4 R, 1 I

8 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

  1. Senate Introduced Feb 3, 2025
  2. Senate Passed Dec 16, 2025

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.

What it does: CRS summary · Introduced in Senate · Feb 3, 2025

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, and may make other changes to the regulations as appropriate.

The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: FDA Modernization Act 3.0

Latest action (Dec 17, 2025): Held at the desk.

Policy area: Health · Origin: Senate · Introduced: Feb 3, 2025

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

  1. Senate Introduced Feb 3, 2025
  2. Senate Passed Dec 16, 2025

No recorded floor vote found.