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S 355Introduced

FDA Modernization Act 3.0

Introduced February 3, 2025

Summary

FDA Modernization Act 3.0This 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. 

Timeline

  1. Held at the desk.

  2. Received in the House.

  3. Message on Senate action sent to the House.

  4. Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)

  5. Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.

  6. Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794)

  7. Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

  8. Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

  9. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

  10. Introduced in Senate

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