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
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
- 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).
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.govHealth
■ 4 R■ 4 D■ 1 I
4 Republicans
1 Independent