S. 355 Passed the Senate Health

FDA Modernization Act 3.0

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.

  1. Introduced
  2. Committee
  3. Passed Senate
  4. Passed House
  5. To President
  6. Became law
Sponsor Sen. Booker, Cory A. [D-NJ] Introduced February 3, 2025 Cosponsors 9 (4 D, 4 R, 1 I) Latest action December 17, 2025

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. 

Summary by the Congressional Research Service, Library of Congress.

Congress.gov

Actions

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

Congressional and federal records come from official public sources: the House Clerk, the U.S. Senate, GovInfo and the Library of Congress (bill status), the Federal Register, and the congress-legislators project. They are copied on a schedule and may lag the official record by a few hours; the official sources govern. News and coverage counts are drawn from the 4Search index and reflect what the press published, not 4Search's views. Nothing here is an endorsement of any candidate, party or position. Terms of use.