FDA Modernization Act 3.0
Latest action · Dec 17, 2025 Held at the desk.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedFeb 3, 2025
- Passed SenateDec 16, 2025
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
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.
Cosponsors 9
Members who signed on, in the order they did. Signatures ran from Feb 3, 2025 to Jul 22, 2025; 8 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| I-ME | Angus S. King Jr. | Original | Feb 3, 2025 |
| D-NM | Ben Ray Luján | Original | Feb 3, 2025 |
| R-MO | Eric Schmitt | Original | Feb 3, 2025 |
| R-LA | John Kennedy | Original | Feb 3, 2025 |
| R-KY | Rand Paul | Original | Feb 3, 2025 |
| D-CT | Richard Blumenthal | Original | Feb 3, 2025 |
| R-KS | Roger Marshall | Original | Feb 3, 2025 |
| D-RI | Sheldon Whitehouse | Original | Feb 3, 2025 |
| D-CA | Adam B. Schiff | Jul 22, 2025 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| Senate | Health, Education, Labor, and Pensions Committee | Referred Feb 3, 2025Discharged Dec 17, 2025 |
Actions 8
Everything that happened, newest first.
- Dec 17, 2025Message on Senate action sent to the House.
- Dec 17, 2025Received in the House.
- Dec 17, 2025Held at the desk.
- Dec 16, 2025Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794)
- Dec 16, 2025Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
- Dec 16, 2025Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
- Feb 3, 2025Introduced in Senate
- Feb 3, 2025Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
In the Congressional Record 2
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| House | Debate and remarks H941 | Earl L. "Buddy" Carter R-GA | Jan 20, 2026 |
| Senate | Debate and remarks S8793, S8794Text printed S8794Amendments S8793, S8794 | Cory A. Booker D-NJ (amendment), Eric Schmitt R-MO (amendment), John Thune R-SD | Dec 16, 2025 |
Amendments 1
Amendments offered to this bill.
| Amendment | Description | Offered by | Status |
|---|---|---|---|
| SA 4057 | In the nature of a substitute. | Cory A. Booker D-NJfor John Thune | Amendment SA 4057 agreed to in Senate by Unanimous Consent. |
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 2821 | FDA Modernization Act 3.0 | Identical bill | Jul 21, 2026 |
Titles 3
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- A bill to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.
- Short Title(s) as Introduced
- FDA Modernization Act 3.0
- Short Title(s) as Passed Senate
- FDA Modernization Act 3.0
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 2
Each version as it was printed, newest first.
- Dec 17, 2025Engrossed in Senate
- Feb 3, 2025Introduced in Senate
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
