CONGANALYTICS
Bills/S 355
S 355Introduced

FDA Modernization Act 3.0

Legislative Progress
Introduced
Committee
Passed House
Passed Senate
Both Chambers
Enacted
SummaryIntroduced in Senate
2025-02-03

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. 

Text Versions2 versions
VersionDateFormats
Engrossed in Senate2025-12-17T05:00:00Z
Introduced in Senate2025-02-03T05:00:00Z
Introduced2025-02-03
119th Congress
Cosponsors9
Co-sponsoring members
Policy AreaHealth
Primary subject
Last Action2025-12-17
Held at the desk.
Legislative Subjects5 total
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationMedical researchResearch administration and funding
Latest Action2025-12-17

Held at the desk.