S 5046
118th Congress
Senate
Health
Administrative law and regulatory procedures
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Medical research
Research administration and funding
FDA Modernization Act 3.0
Introduced: September 12, 2024
Introduced by:
Booker, Cory A.
Democratic
· New Jersey
See on congress.gov
Everywhere this bill has been
9 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 16, 2024
Held at the desk.
Dec 16, 2024
Received in the House.
Dec 13, 2024
Message on Senate action sent to the House.
Dec 12, 2024
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7044)
Dec 12, 2024
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Dec 12, 2024
Measure laid before Senate by unanimous consent. (consideration: CR S7044)
Dec 12, 2024
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Sep 12, 2024
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 12, 2024
Introduced in Senate
Plain-English summary
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.
What's happening now
Held at the desk.
Committees of jurisdiction
1