FDA Modernization Act 3.0

Sponsored bySen. Booker, Cory A. [D-NJ]NJ· Introduced 3 février 2025

Open on Congress.gov

Cosponsors

Actions

Amendments

Committees

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Since introduced

Introduced

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Passed Chamber

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Enacted

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Latest action

Held at the desk.

17 décembre 2025·7 months ago

Summary

Introduced in Senate · Updated 4 juin 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.

Timeline

10 actions

Message on Senate action sent to the House.
17 décembre 2025 · Floor
Received in the House.
17 décembre 2025 · Floor
Held at the desk.
17 décembre 2025 · Floor
Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794)
16 décembre 2025 · Floor
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
16 décembre 2025 · Committee
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
16 décembre 2025 · Discharge
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
16 décembre 2025 · Floor
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
16 décembre 2025 · Floor
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
3 février 2025 · IntroReferral
Introduced in Senate
3 février 2025 · IntroReferral

Sponsorship

9 cosponsors

Sponsor

Sen. Booker, Cory A. [D-NJ]NJ

Cosponsors

Democrat444%
Republican444%
Independent111%

Democrat:Sen. Schiff, Adam B. [D-CA]CA
Independent:Sen. King, Angus S., Jr. [I-ME]ME
Republican:Sen. Schmitt, Eric [R-MO]MO
Democrat:Sen. Whitehouse, Sheldon [D-RI]RI
Republican:Sen. Kennedy, John [R-LA]LA
Republican:Sen. Marshall, Roger [R-KS]KS
Republican:Sen. Paul, Rand [R-KY]KY
Democrat:Sen. Blumenthal, Richard [D-CT]CT
Democrat:Sen. Luján, Ben Ray [D-NM]NM

Classification

Policy area

Health

Legislative subjects

Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationMedical researchResearch administration and funding

Committees

Health, Education, Labor, and Pensions Committee
Senate · Standing
- Referred To3 Feb 2025
- Discharged From17 Dec 2025

Cosponsor momentum

Cumulative over time

Amendments

SAMDT 4057Agreed
In the nature of a substitute.
16 décembre 2025

Track FDA Modernization Act 3.0 as it moves through Congress