S 355

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. 

Bill status

Status

Passed Senate

Sponsor

Sen. Cory A. Booker [D-NJ]

Cosponsors

9

Policy area

Health

Introduced

2025-02-03

Latest action

2025-12-17: Held at the desk.

Committee referrals

• Health, Education, Labor, and Pensions Committee: Senate · Discharged From · 2025-12-17
• Health, Education, Labor, and Pensions Committee: Senate · Referred To · 2025-02-03

Recent actions

• 2025-12-17: Held at the desk.
• 2025-12-17: Received in the House.
• 2025-12-17: Message on Senate action sent to the House.
• 2025-12-16: Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
• 2025-12-16: Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.