FDA Modernization Act 3.0

Senate Bill

S. 355

119th Congress

FDA Modernization Act 3.0

Held at the desk.

Introduced:Dec 17, 2025

Primary Sponsor

Cory Booker

D - NJ

Cosponsors

9

Quick Stats

Policy Area

Health

Summary

The FDA Modernization Act 3.0 would require the FDA to update its regulations to replace references to 'animal' tests with 'nonclinical' tests. This would allow drug developers to use more modern research methods instead of animal testing when developing new medicines.

Latest Action

Held at the desk.

Introduced12/17/2025

StatusHeld at the desk.

ChamberSenate

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Vote Prediction

FDA Modernization Act 3.0

The FDA Modernization Act 3.0 would require the FDA to update its regulations to replace references to 'animal' tests with 'nonclinical' tests. This would allow drug developers to use more modern research methods instead of animal testing when developing new m

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The FDA Modernization Act 3.0 would require the FDA to update its regulations to replace references to 'animal' tests with 'nonclinical' tests. This would allow drug developers to use more modern research methods instead of animal testing when developing new medicines.

Bill Number: 355
Introduced: 12/17/2025
Status: Held at the desk.
Policy Area: Health

Data from Congress.gov

AI-generated summary

Fact Sheet

Title: FDA Modernization Act 3.0
Bill Number: 355
Sponsor: No sponsor
Status: Held at the desk.
Introduced: 12/17/2025
Summary: The FDA Modernization Act 3.0 would require the FDA to update its regulations to replace references to 'animal' tests with 'nonclinical' tests. This would allow drug developers to use more modern research methods instead of animal testing when developing new medicines.

Data from Congress.gov

AI Summary

Plain-English explanation of this bill

The FDA Modernization Act 3.0 would require the FDA to update its regulations to replace references to 'animal' tests with 'nonclinical' tests. This would allow drug developers to use more modern research methods instead of animal testing when developing new medicines.

Last updated: 12/26/2025

Official Summary

Congressional Research Service summary

FDA Modernization Act 3.0This 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.

Key Points

Main provisions of the bill

Requires the FDA to update regulations to replace references to 'animal' tests with 'nonclinical' tests
Allows drug developers to use more modern research methods instead of animal testing when developing new drugs
Aims to modernize the drug development process by reducing reliance on animal testing

How This Impacts Americans

Potential effects on citizens and communities

This bill would impact the pharmaceutical industry, allowing them more flexibility in how they research and develop new drugs. It could lead to faster, more efficient drug development that relies less on animal testing. Consumers may ultimately benefit from a wider range of safe, effective medicines reaching the market.

Policy Areas

Primary Policy Area

Health

Related Subjects

Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Medical research

Research administration and funding

Scope & Jurisdiction

Jurisdiction Level

federal

Congressional Session

119th Congress

Citation Reference

355, 119th Congress (2025). "FDA Modernization Act 3.0". Source: Voter's Right Platform. https://votersright.org/bills/119-s-355

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