S. 355 · Where this bill is now
In the House
Passed the Senate Dec 16, 2025. Received Dec 17, 2025; no House vote yet
What this bill does
In plain words · AI-written from the official summaryFDA updates drug testing rules to allow alternatives
The FDA already authorized alternatives to animal testing for new experimental drugs. This bill requires the FDA to update its official rules within one year to reflect that change. The updated rules will replace references to animal tests with references to other types of testing throughout the FDA's procedures for investigational new drugs.
How it affects you
This mainly affects pharmaceutical companies developing new drugs, as it gives them official, updated guidance on which testing methods the FDA will accept. For people interested in reducing animal testing in drug development, this makes the FDA's regulations align with a practice that's already legally allowed.
Read the official summary (Introduced in Senate, Feb 3, 2025)
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.
Written by AI (Claude) using only the official summary by the Congressional Research Service, the Library of Congress’s nonpartisan research staff. It can miss nuance, so check the official summary and the bill text for details.
1st SessionS. 355
AN ACT
FDA Modernization Act 3.0
Sponsor: Sen. Cory A. Booker (D-NJ) · Introduced Feb 3, 2025 · Health · 2 versions of the text
Sources: Congress.gov actions and votes · bill text from GovInfo · latest official action Dec 17, 2025: “Held at the desk.”