Bill · S. 355· Senate(119-S-355)
FDA Modernization Act 3.0
- Introduced
- 2/3/2025
- Last activity
- 12/17/2025 — Held at the desk.
- Sponsored by
- Cory Booker
- Cosponsors
- - 4 - 4
- Introduced
- Passed Senate
- Awaiting House
What this bill would do
The FDA Modernization Act 3.0 requires the Secretary of Health and Human Services, via the FDA Commissioner, to publish an interim final rule regarding nonclinical testing methods. This rule aims to implement amendments previously made to the Federal Food, Drug, and Cosmetic Act. The mandate involves replacing specific references to "animal" tests, data, studies, models, and research with "nonclinical" testing terms within various sections of the Code of Federal Regulations. Additionally, the rule must add the definition of "nonclinical test" to several specific regulatory sections. The interim final rule is set to become effective immediately without the need to demonstrate good cause.
Yes· 3 of 4
Does this make health care easier to get in general?+3
The bill updates regulatory language to allow for nonclinical testing methods, which may facilitate faster drug development and access.
Does this put more money into medical research?+2
By modernizing the regulatory framework for nonclinical tests, the bill supports more diverse research methodologies.
Would students be better off under this?+1
Modernizing testing regulations can expand opportunities for research and study in scientific fields.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Regulatory Consistency: The bill aims to ensure implementation of amendments to section 505(i) of the Federal Food, Drug, and Cosmetic Act (Sec. 2(a)(1)).
-
Updated Definitions: The rule will add the definition of "nonclinical test" to several sections of title 21, Code of Federal Regulations, including sections 312.3, 314.3, 315.2, and 601.31 (Sec. 2(a)(1)(B)).
Potential Negative Impacts for People
- Immediate Regulatory Changes: The interim final rule will become immediately effective without requiring the Secretary of Health and Human Services to demonstrate good cause (Sec. 2(a)(3)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Healthcare
- Improves Healthcare Access+3Increases Research Funding+2
- Demographic And Interest Groups
- Good For Students+1
- Governance And Ideology
- Improves Government Transparency+1
| Updated | Bill | Title | Policy Area |
|---|---|---|---|
| 10 months ago | In the nature of a substitute. |
- 12/17/2025
- Message on Senate action sent to the House.
- Held at the desk.
- Received in the House.
- 12/16/2025
- Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
- Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794)
- Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
- Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
- 7/22/2025
- 1 Cosponsor added.
- 2/3/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 8 Cosponsors added.
- Introduced in Senate
One bill Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Richard BlumenthalDemocrat · Connecticut
Angus KingIndependent · Maine
John KennedyRepublican · Louisiana
Ben LujánDemocrat · New Mexico
Roger MarshallRepublican · Kansas
Rand PaulRepublican · Kentucky
Adam SchiffDemocrat · California
Eric SchmittRepublican · Missouri
Sheldon WhitehouseDemocrat · Rhode Island