119th Congress
S. 355
FDA Modernization Act 3.0
- Introduced
- In committee
- Passed Senate
- Passed House
- To President
- Became law
- Sponsor
- Cory A. Booker(D-NJ)
- Introduced
- Feb 3, 2025
- Policy area
- Health
- Committees
- Senate Committee on Health, Education, Labor, and Pensions
- Official text
- Engrossed in Senate · Congress.gov page
Cosponsors (9)
Original cosponsors (8)
- Angus S. King, Jr. (I-ME)
- Ben Ray Luján (D-NM)
- Eric Schmitt (R-MO)
- John Kennedy (R-LA)
- Rand Paul (R-KY)
- Richard Blumenthal (D-CT)
- Roger Marshall (R-KS)
- Sheldon Whitehouse (D-RI)
Added later (1)
- Adam B. Schiff (D-CA) · Jul 22, 2025
Summary
Summary by the Congressional Research Service· describes the “Introduced in Senate” version
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.
Roll-call votes
No recorded votes on this bill.
Actions
- Dec 17, 2025 · House
Held at the desk. - Dec 17, 2025 · House
Received in the House. - Dec 17, 2025 · Senate
Message on Senate action sent to the House. - Dec 16, 2025 · Senate
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794) - Dec 16, 2025
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent. - Dec 16, 2025 · Senate
Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794) - Dec 16, 2025 · Senate
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. - Feb 3, 2025 · Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. - Feb 3, 2025
Introduced in Senate