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Bill · 119th Congress · S 355

FDA Modernization Act 3.0

Refreshed 4 h ago

Introduced 2025-02-03Topic: health care · public health

Summary

Summary by the Congressional Research Service

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.

Full text and official record on Congress.gov

Sponsors

Action history

DateChamberActionStatus effect
2025-12-17HouseHeld at the desk.
2025-12-17HouseReceived in the House.
2025-12-17SenateMessage on Senate action sent to the House.
2025-12-16SenatePassed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
2025-12-16Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.floor pass
2025-12-16SenateMeasure laid before Senate by unanimous consent. (consideration: CR S8793-8794)
2025-12-16SenateSenate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.report
2025-12-16Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.report
2025-02-03SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.refer
2025-02-03Introduced in Senateintroduce
Source: GovInfo Bill Status (Library of Congress), fetched 2026-09-11. Provisions and opinion polling arrive in a later release.