S 355 United States Senate · 119th Congress

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, 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.

Issues: ✓ Healthcare

Bill status passed 3 of 5 stages cleared

Introduction

Feb 2025

Committee Review

Dec 2025

Senate Passage

Dec 2025

House Passage

President

Introduced Feb 3, 2025 Last action Dec 17, 2025

Maddy AI version diff · 1 comparison

What changed between versions

Introduced in Senate → Engrossed in Senate · 3 edits · Dec 17, 2025

MINOR

The bill was restructured to consolidate its requirements into fewer subsections and, most significantly, removed a provision that had allowed the Secretary of Health and Human Services to make additional discretionary changes to FDA regulations beyond those explicitly listed. The definition of 'nonclinical test' is now embedded directly into the rule requirement rather than standing as a separate section, making it an explicit mandatory component of the interim final rule.

SCOPE

Removed the provision (old subsection (b)(2)) that allowed the Secretary to make additional changes to the listed CFR sections beyond what was explicitly required. This narrows the rule's scope to only the specific replacements and definition additions now stated in the text.

REQUIREMENT

The requirement to add the 'nonclinical test' definition from section 505(z) of the FDCA to CFR sections 312.3, 314.3, 315.2, and 601.31 was moved from a standalone subsection (c) into subpart (B) of the main rule requirement, making it an explicit part of what the interim final rule must do rather than a separate obligation.

TECHNICAL

The overall structure was reorganized: old subsections (a), (b), (c), and (d) were consolidated into two subsections (a) and (b). The technical amendment (renumbering section 505(z) to 505(aa)) moved from subsection (d) to subsection (b).

Floor votes

How they voted

This bill passed the Senate by voice vote (no roll call recorded).

Full legislative history

Actions timeline

Total actions

Key actions

Committee

Dec 16, 2025

Upper · Passed

Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)

upper

Dec 16, 2025

Upper · Passed

Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.

upper

Dec 16, 2025

Upper · Passed

Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

upper

Feb 3, 2025

Committee

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

upper

Feb 3, 2025

Introduced

Introduced in Senate

upper

1 primary · 9 co-sponsors