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S. 355 Senate Health

FDA Modernization Act 3.0

Introduced
Feb 3, 2025
Sponsor
Sen. Booker, Cory A. (D-NJ)
View on Congress.gov

STAGE 5 OF 8 — SENATE FLOOR

Currently in the Senate. Last action: held at the desk on Dec 17, 2025.

  1. Senate Introduced in Senate Feb 3, 2025
  2. Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Feb 3, 2025
  3. Senate Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. Dec 16, 2025
  4. Senate Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794) Dec 16, 2025
  5. Senate Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent. Dec 16, 2025
  6. Senate Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794) Dec 16, 2025
  7. Senate Message on Senate action sent to the House. Dec 17, 2025
  8. House Received in the House. Dec 17, 2025
  9. House Held at the desk. Dec 17, 2025

Cosponsors

9

Subjects

Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationMedical researchResearch administration and funding

Committees

  • Health, Education, Labor, and Pensions Committee
    • Discharged From , Dec 17, 2025
    • Referred To , Feb 3, 2025

Summary

FDA Modernization Act 3.0This 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. 

Summary as of: Introduced in Senate

Bill Text

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