S. 355

119th Congress

Introduced

FDA Modernization Act 3.0

Sponsored byDemocrat:Sen. Booker, Cory A. [D-NJ]NJ· Introduced 3 February 2025
Open on Congress.gov

9

Cosponsors

10

Actions

1

Amendments

1

Committees

—

Since introduced

Introduced
Committee
Passed Chamber
Passed Both
Enacted
Step 0 of 0
Latest action

Held at the desk.

17 December 2025·7 months ago

Summary

Introduced in Senate · Updated 4 June 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

  1. Message on Senate action sent to the House.

    17 December 2025 · Floor

  2. Received in the House.

    17 December 2025 · Floor

  3. Held at the desk.

    17 December 2025 · Floor

  4. Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794)

    16 December 2025 · Floor

  5. Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

    16 December 2025 · Committee

  6. Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

    16 December 2025 · Discharge

  7. Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.

    16 December 2025 · Floor

  8. Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)

    16 December 2025 · Floor

  9. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    3 February 2025 · IntroReferral

  10. Introduced in Senate

    3 February 2025 · IntroReferral

Sponsorship

9 cosponsors

Sponsor

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

Cosponsors

  • Democrat444%
  • Republican444%
  • Independent111%

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

1

  • Health, Education, Labor, and Pensions Committee

    Senate · Standing

    • Referred To3 Feb 2025
    • Discharged From17 Dec 2025

Cosponsor momentum

Cumulative over time

Cosponsors grew from 8 on 3 February 2025 to 9 on 22 July 2025.

Amendments

1

  • SAMDT 4057Agreed

    In the nature of a substitute.

    16 December 2025

Pelosi Tracker
Follow on XJoin our Discord
PoliticiansBillsPortfoliosPricingAboutLegalTerms of ServicePrivacy Policy
Français
© 2026 - All rights reserved. Powered by Vantara Labs
This website is an independent, third-party platform. It is not affiliated with, endorsed by, or in any way associated with Nancy Pelosi, her office, or her representatives. Any use of her name is solely for the purpose of discussing publicly available information.The information provided on this website is for informational and educational purposes only and is not intended to serve as, nor should it be construed as, financial or investment advice. The data presented here is sourced from publicly available filings and records. While we strive for accuracy, timeliness, and completeness, we do not guarantee that all information is error-free or current.