FDA Modernization Act 3.0
Official title: A bill to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.
Amendments propose changes to this bill. Members vote on amendments separately before the final bill vote. An agreed amendment becomes part of the bill; a failed amendment does not.
1 agreed to
| Amendment | Sponsor | Status |
|---|---|---|
| SAMDT 4,057 | Booker, Cory A. | Agreed to |
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Held at the desk.
FDA Modernization Act 3.0
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.
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.
The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.
- Engrossed in Senate Formatted Text PDF Formatted XML
- Introduced in Senate Formatted Text PDF Formatted XML
- PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
- GSK (FKA GLAXOSMITHKLINE INC.)
- THE PERSONAL CARE PRODUCTS COUNCIL
- FRAGRANCE CREATORS ASSOCIATION
- UNILEVER UNITED STATES, INC.
- HOLLAND & KNIGHT LLP
Bodies those filers lobbied
- SENATE
- HOUSE OF REPRESENTATIVES
- Food & Drug Administration (FDA)
- Health & Human Services, Dept of (HHS)
- U.S. Trade Representative (USTR)
- Centers For Medicare and Medicaid Services (CMS)
- Patent & Trademark Office (PTO)
- Drug Enforcement Administration (DEA)
Cite this page
U.S. Congress. (2026). S. 355: FDA Modernization Act 3.0. 119th Congress. Open America. https://openamerica.io/bill/119-S-355/
"S. 355: FDA Modernization Act 3.0." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-S-355/.
S. 355, 119th Cong. (2026), https://openamerica.io/bill/119-S-355/.
[S. 355: FDA Modernization Act 3.0](https://openamerica.io/bill/119-S-355/)