FDA Modernization Act 3.0
The FDA Modernization Act 3.0 requires the FDA to issue a final rule within 180 days of enactment to implement regulations for nonclinical testing methods used in drug development. This affects pharmaceutical companies developing new drugs by establishing standardized requirements for preclinical safety testing before human trials. The bill also makes a technical amendment to renumber a subsection related to clinical trial diversity plans, clarifying existing provisions without changing their substance. The key change is the FDA's obligation to finalize these testing regulations, aiming to modernize the drug approval process.
Bill status
passed
3 of 5 stages cleared
Introduction
Sep 2024
Committee Review
Dec 2024
Senate Passage
Dec 2024
House Passage
President
Introduced Sep 12, 2024
Last action Dec 16, 2024
Floor votes
How they voted
This bill passed the Senate by voice vote (no roll call recorded).
Full legislative history
Actions timeline
Total actions
9
Key actions
3
Committee
2
Dec 12, 2024
Upper · Passed
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7044)
upper
Dec 12, 2024
Upper · Passed
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
upper
Dec 12, 2024
Upper · Passed
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
upper
Sep 12, 2024
Committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
upper
Sep 12, 2024
Introduced
Introduced in Senate
upper
1 primary · 9 co-sponsors
Sponsors
Role
Legislator
Party
State
District
P
Cory A. Booker
DDemocratic
Co
Angus S. King, Jr.
IIndependent
Co
Ben Ray Luján
DDemocratic
Co
Eric Schmitt
RRepublican
Co
John Kennedy
RRepublican
Co
Mike Braun
RRepublican
Co
Rand Paul
RRepublican
Co
Richard Blumenthal
DDemocratic
Co
Roger Marshall
RRepublican
Co
Sheldon Whitehouse
DDemocratic
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