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S 355 119th Congress Senate Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Medical research Research administration and funding

FDA Modernization Act 3.0

Introduced: February 3, 2025 Introduced by: Booker, Cory A. Democratic · New Jersey See on congress.gov
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 Everywhere this bill has been 9 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 17, 2025
Held at the desk.
Dec 17, 2025
Message on Senate action sent to the House.
Dec 17, 2025
Received in the House.
Dec 16, 2025
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Dec 16, 2025
Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794)
Dec 16, 2025
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Dec 16, 2025
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
Feb 3, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Feb 3, 2025
Introduced in Senate
 Amendments to this bill 1

1 agreed to

AmendmentSponsorPurposeStatusLatest action
SAMDT 4,057 Booker, Cory A. In the nature of a substitute. Agreed to Dec 16, 2025
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 Plain-English summary Congressional Research Service

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. 

What's happening now December 17, 2025

Held at the desk.

 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 38

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

See all 38 filings →
 Cosponsors 9
All 9 Democratic 4 Republican 4 Independent 1
D
Schiff, Adam B.
California · Jul 22, 2025
 D
Blumenthal, Richard
Connecticut · Feb 3, 2025
 R
Kennedy, John
Louisiana · Feb 3, 2025
 I
King, Angus S., Jr.
Maine · Feb 3, 2025
 D
Luján, Ben Ray
New Mexico · Feb 3, 2025
 R
Marshall, Roger
Kansas · Feb 3, 2025
 R
Paul, Rand
Kentucky · Feb 3, 2025
 R
Schmitt, Eric
Missouri · Feb 3, 2025
 D
Whitehouse, Sheldon
Rhode Island · Feb 3, 2025
Cite this page click to expand
APA
U.S. Congress. (2026). S. 355: FDA Modernization Act 3.0. 119th Congress. Open America. https://openamerica.io/bill/119-S-355/
MLA
"S. 355: FDA Modernization Act 3.0." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-S-355/.
Bluebook (legal)
S. 355, 119th Cong. (2026), https://openamerica.io/bill/119-S-355/.
Markdown link
[S. 355: FDA Modernization Act 3.0](https://openamerica.io/bill/119-S-355/)
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