FDA Modernization Act 3.0 passed the Senate 316 days after introduction and awaits a vote in the House
Written by the Congressional Research Service [2]. 111 words.
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.
- Committees
- Senate Health, Education, Labor, and Pensions Committee
- Policy area
- Health: 122 of 9,357 bills became law, 113th–118th (1.3%)
- Sponsor
- 3 of 567 bills enacted since 2013
- Text versions
- 2, from introduced in senate to engrossed in senate · 434 words
- Subjects
- Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationMedical researchResearch administration and funding
- Latest action
- Dec 17, 2025: Held at the desk.
- Records
- Congress.gov · Bill text
Each bill appears once, under its strongest link. 1 in all.
Identical or companion · 1
- 119th H.R. 2821 FDA Modernization Act 3.0 R · Passed one chamber