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S 355 Passed a chamber

Requires the FDA to issue an interim final rule within one year that replaces references to "animal" testing with "nonclinical" testing across its drug and biologic regulations, and makes the rule effective immediately.

Official title: FDA Modernization Act 3.0

Next stop House: awaiting action
Timeline each lane is a chamber; dates pull from congress.gov actions
House
Received 17-DEC-2025
Senate
Introduced 03-FEB-2025
Referred 03-FEB-2025
Passed 16-DEC-2025
Key points
  • Directs the Secretary of Health and Human Services, through the FDA Commissioner, to publish an interim final rule not later than 1 year after enactment.
  • Replaces "animal" tests, data, studies, models, and research with "nonclinical" terms in listed sections of Title 21 of the Code of Federal Regulations.
  • Adds the statutory definition of "nonclinical test" to sections 312.3, 314.3, 315.2, and 601.31 of those regulations.
  • Waives the usual notice-and-comment requirement so the interim rule takes effect immediately, and redesignates the second subsection (z) of section 505 of the Federal Food, Drug, and Cosmetic Act as subsection (aa).
AI-generated from the Engrossed in Senate text of 17-DEC-2025 · verify · report an error
Official CRS summary

Covers an older version. The newest CRS summary describes the bill as of "Introduced in Senate" (03-FEB-2025); the text has changed since (Engrossed in Senate, 17-DEC-2025).

CRS is the Library of Congress's nonpartisan research office. Read it on congress.gov
Committee referrals (1) Policy area

Health

Sponsor Cory A. Booker (D-NJ) Cosponsors · 9
■ 4 R■ 4 D■ 1 I
1 Independent