FDA Modernization Act 3.0
Introduced Feb 3, 2025 by Sen. Cory A. Booker
The Senate passed it. The House has to pass it before it can reach the President.
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.
No recorded roll-call vote on this bill — it may have passed by voice vote or unanimous consent, which don't record individual votes.
- Dec 17, 2025Held at the desk.
- Dec 17, 2025Received in the House.
- Dec 17, 2025Message on Senate action sent to the House.
- Dec 16, 2025Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
- Dec 16, 2025Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
- Dec 16, 2025Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794)
- Dec 16, 2025Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
- Feb 3, 2025Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Feb 3, 2025Introduced in Senate