senateStanding
Health, Education, Labor, and Pensions Committee
- Referred To
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S. 355Passed Senate
FDA Modernization Act 3.0
Introduced: Feb 3, 2025
Latest action date: Dec 17, 2025
Latest development
Held at the desk.
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- Congress
- 119th Congress
- Introduced
- Feb 3, 2025
- Recorded roll calls
- 0
Status detail: The full action history records passage in the Senate.
Plain-language overview
What this bill does
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.
Official summary from Congress.gov.
Civixly topics
What this legislation is about
Civixly topics make federal and state legislation comparable. They are derived from the official CRS policy area and legislative subjects.
Official CRS policy area
Health
View 5 official legislative subjects
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationMedical researchResearch administration and funding
Committee activity
Committees and subcommittees that received, reviewed, marked up, or reported this legislation.
Official committee record ↗
Amendments
Proposed changes to this measure, with their latest official outcome or action from Congress.gov.
View amendments1 amendment
S.Amdt. 4057senateAgreed toDec 16, 2025
In the nature of a substitute.
Latest action: Amendment SA 4057 agreed to in Senate by Unanimous Consent.
Checked against Congress.gov Oct 11, 2026.
Action timeline
Newest action first. Action language comes from the official Congress.gov record.
View full action timeline10 actions
Held at the desk.
FloorHouse floor actionsReceived in the House.
FloorHouse floor actionsMessage on Senate action sent to the House.
FloorSenatePassed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
FloorLibrary of CongressPassed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
FloorSenateSenate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
DischargeSenateSenate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
CommitteeLibrary of CongressMeasure laid before Senate by unanimous consent. (consideration: CR S8793-8794)
FloorSenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.
IntroReferralSenateIntroduced in Senate
IntroReferralLibrary of Congress
Roll-call votes
Recorded House and Senate votes connected to this bill. Your representatives appear first when available.
No connected roll-call votes are currently available for this bill.
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