FDA Modernization Act 3.0
Sponsored By: Senator Sen. Booker, Cory A. [D-NJ]
Passed Senate
Summary
Replaces references to “animal tests” with a formal, broader definition of “nonclinical tests” across FDA rules. The bill would force regulatory language changes and add a statutory definition so alternative test methods are explicitly recognized in key drug and biologic rules.
Show full summary
- Drug and biotech sponsors and researchers would see updated regulatory wording across multiple Code of Federal Regulations parts for drugs and biologics, including parts 312, 314, and 601, clarifying where nonclinical tests apply.
- The Secretary of Health and Human Services, acting through the Food and Drug Administration Commissioner, would have to publish an interim final rule within one year. That rule would take effect immediately as an interim final rule despite the usual notice requirements.
- The bill also renumbers a subsection of section 505 of the Federal Food, Drug, and Cosmetic Act from (z) to (aa) to keep statutory citations consistent with prior amendments.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
New FDA rules for nonclinical testing
If enacted, the FDA would publish a rule within one year. The rule would take effect right away when published. It would replace many references to “animal” tests with “nonclinical” tests in FDA drug and biologic rules. It would also add a clear definition of “nonclinical test” to several FDA regulations. Drug makers and researchers would follow the updated wording, which could help FDA and companies adopt newer nonclinical methods.
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Sponsors & CoSponsors
Sponsor
Sen. Booker, Cory A. [D-NJ]
NJ • D
Cosponsors
Eric Schmitt
MO • R
Sponsored 2/3/2025
Angus King
ME • I
Sponsored 2/3/2025
Sen. Kennedy, John [R-LA]
LA • R
Sponsored 2/3/2025
Sen. Whitehouse, Sheldon [D-RI]
RI • D
Sponsored 2/3/2025
Sen. Marshall, Roger [R-KS]
KS • R
Sponsored 2/3/2025
Richard Blumenthal
CT • D
Sponsored 2/3/2025
Sen. Paul, Rand [R-KY]
KY • R
Sponsored 2/3/2025
Sen. Luján, Ben Ray [D-NM]
NM • D
Sponsored 2/3/2025
Sen. Schiff, Adam B. [D-CA]
CA • D
Sponsored 7/22/2025
Roll Call Votes
No roll call votes available for this bill.
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