S.355

FDA Modernization Act 3.0

Chamber Passed·12/17/25

FDA Modernization Act 3.0 requires the FDA to replace animal testing references with nonclinical testing in regulations.

FDA Modernization Act 3.0 mandates the Secretary of Health and Human Services to publish an interim final rule within one year of enactment. This rule will replace references to animal tests with nonclinical tests in specific sections of the Code of Federal Regulations. The interim final rule will become effective immediately without requiring a demonstration of good cause. The definition of "nonclinical test" will be added to relevant sections of the Code of Federal Regulations.

Included in complete analysis

  • Overview
  • Core Provisions
  • Implementation
  • Impact
  • Legal Framework
  • Critical Issues

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Where it stands

Last
Passed the Senate · Dec 17, 2025
Current
The House
Next
House floor vote

Sponsors

Democratic CaucusRepublican Caucus

History

Dec 17, 2025

Senate

Message on Senate action sent to the House.

Dec 17, 2025

House

Received in the House.

Dec 17, 2025

House

Held at the desk.