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FDA Modernization Act 3.0

S. 355 Sen. Cory Booker (D-NJ) Passed Senate
Bill text PDF
  1. Introduced Feb 3
  2. Committee Feb 3
  3. Passed Senate Dec 16
  4. Passed House Next
  5. To President Not yet
  6. Law Not yet
Where it stands
Passed Senate, Dec 16, 2025Next: House vote
315d ago Dec 17, 2025: Held at the desk.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
1company, 4 filings
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Summary

FDA Modernization Act 3.0

Full summary3 paragraphs

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.

Library of Congress summary, Feb 3, 2025

Summary versions
  • Introduced in SenateFeb 3, 2025

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 27, 2026.