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119-s-355119th CongressWALLET

FDA Modernization Act 3.0

Sponsored By: Senator Booker, Cory A. [D-NJ]

Passed Senate

Summary

Modernize FDA rules by replacing references to “animal” tests with a broader nonclinical standard and force quick regulatory updates. This bill would require the Department of Health and Human Services to publish rules that change regulatory language and add a definition for nonclinical testing to key FDA regulations.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

FDA would update nonclinical testing rules

If enacted, the FDA would have to publish an interim final rule within one year. The rule would replace the word "animal" with "nonclinical" in certain FDA drug and biologic rules. It would add a formal definition of "nonclinical test" to several rule sections. The rule would take effect as soon as it is published, without showing good cause. This mainly affects drug and device makers and researchers, not most households.

Sponsors & CoSponsors

Sponsor

Booker, Cory A. [D-NJ]

NJ • D

Cosponsors

  • Sen. Schmitt, Eric [R-MO]

    MO • R

    Sponsored 2/3/2025

  • Sen. King, Angus S., Jr. [I-ME]

    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

  • Sen. Blumenthal, Richard [D-CT]

    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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