Senate Bill
Cory Booker
D - NJ
Cosponsors
9
Policy Area
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
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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
Congressional Research Service summary
<p><strong>FDA Modernization Act 3.0</strong></p><p>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. </p><p>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. </p><p>The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule. </p>
Main provisions of the bill
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.
Primary Policy Area
Related Subjects
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