Bills · S 355
PASSED SENATE· 119TH CONGRESS
Senate BillS 355Drug safety, medical device, and laboratory regulationMedical research
FDA Modernization Act 3.0
INTRO FEB 3· LAST ACTION DEC 17
READING
3MIN
COSPONSORS
9BIPARTISAN
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- One chamber only
LEGISLATIVE PROGRESS
STEP 4 / 8Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenThis bill matters because it forces the Food and Drug Administration (FDA) to modernize its drug testing regulations. For many years, animal testing has been a standard, often mandatory, step for drug approval. However, scientific advances have led to sophisticated new methods, like using human cells, tissues, or computer models, which can sometimes provide more accurate results for human responses than animal tests.
If this bill becomes law, it ensures that the FDA’s official rules clearly allow and define these "nonclinical" testing methods. This could accelerate the development and approval of new drugs by giving pharmaceutical companies more flexibility, potentially bringing new treatments to patients faster. It also addresses ethical concerns by reducing the need for animal testing. If this bill does not pass, the FDA may still eventually update its rules, but this legislation puts a specific deadline on the agency, pushing for quicker adoption of these modern scientific practices.
KEY PROVISIONS
5AI-extractedPROVISION 01
Requires the Secretary of Health and Human Services (acting through the FDA Commissioner) to publish an interim final rule within one year of the bill's enactment.
This sets a firm deadline for the FDA to update its regulations, ensuring the changes happen promptly.
PROVISION 02
The interim final rule must amend specific sections of federal regulations to replace references to "animal" tests with "nonclinical" tests.
This formally integrates modern, non-animal testing methods into the drug approval process, aligning regulations with scientific advancements.
PROVISION 03
The rule must add the definition of "nonclinical test" to key regulatory sections.
This provides clarity and consistency for drug developers regarding what constitutes an acceptable alternative to animal testing.
PROVISION 04
The interim final rule will become effective immediately upon publication, without requiring the FDA to demonstrate "good cause" for immediate action.
This speeds up the implementation of these regulatory changes, allowing for quicker adoption of nonclinical testing methods.
PROVISION 05
Includes a technical amendment to renumber a subsection in the Federal Food, Drug, and Cosmetic Act to resolve a numbering conflict.
This ensures legal consistency and avoids confusion within the existing law.
SPONSORSHIP
1 + 9
D· New Jersey
YRS IN OFFICE
12
BILLS LED
125
COSPONSOR BREAKDOWNBIPARTISAN · 100%
DEM 4 REP 4 IND 1
ACTION TIMELINE
9 EVENTSDEC 17
Message on Senate action sent to the House.
DEC 17
Received in the House.
DEC 17
Held at the desk.
DEC 16
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
BILL INFO
TypeSenate Bill
NumberS 355
Congress119th
StatusPassed Senate
IntroducedFeb 3, 2025
Last actionDec 17, 2025
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PASSED SENATE· 119TH CONGRESS · HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE · INTRODUCED FEB 3, 2025
Senate BillS 355Drug safety, medical device, and laboratory regulationMedical research
FDA Modernization Act 3.0
INTRODUCED FEB 3, 2025· LAST ACTION DEC 17, 2025
PASSAGE CHANCES
—%
READING
3 min
COSPONSORS
9
COMPLEXITY
Moderate
