S 355 · FDA Modernization Act 3.0
Held at the desk.
- Introduced
- Feb 3, 2025
- Latest action
- Dec 17, 2025
- Sponsor
- Sen. Cory A. Booker [D-NJ]
- Policy area
- Health
- Cosponsors
- 9
Summary
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.
Recent actions
- Dec 17, 2025 Held at the desk.
- Dec 17, 2025 Received in the House.
- Dec 17, 2025 Message on Senate action sent to the House.
- Dec 16, 2025 Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
- Dec 16, 2025 Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
- Dec 16, 2025 Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794)
- Dec 16, 2025 Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
- Dec 16, 2025 Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Votes
No recorded votes are available for this bill.