S 5046 United States Senate · 118th Congress

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