FDA Modernization Act 3.0

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. 

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Timeline

1. 3 February 2025

   Introduced

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

   Source: IntroReferral

2. 3 February 2025

   Introduced

   Introduced in Senate

   Source: IntroReferral

3. 16 December 2025

   Passed

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

   Source: Floor

4. 16 December 2025

   Floor

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

   Source: Floor

5. 16 December 2025

   Discharge

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

   Source: Discharge

6. 16 December 2025

   Committee

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

   Source: Committee

7. 17 December 2025

   Floor

   Held at the desk.

   Source: Floor

8. 17 December 2025

   Floor

   Received in the House.

   Source: Floor

9. 17 December 2025

   Floor

   Message on Senate action sent to the House.

   Source: Floor

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

3 official files

• Engrossed in Senate

  Engrossed in Senate · EN · 17 December 2025

  DownloadOpen at official source

• Introduced in Senate

  Introduced in Senate · EN · 3 February 2025

  DownloadOpen at official source

• Introduced in Senate

  summary · EN · 3 February 2025

  Open at official source

Sponsors

• Sen. Booker, Cory A. [D-NJ] · D · Sponsor
• Sen. Schmitt, Eric [R-MO] · R · Sponsor
• Sen. King, Angus S., Jr. [I-ME] · I · Sponsor
• Sen. Kennedy, John [R-LA] · R · Sponsor
• Sen. Whitehouse, Sheldon [D-RI] · D · Sponsor
• Sen. Marshall, Roger [R-KS] · R · Sponsor
• Sen. Blumenthal, Richard [D-CT] · D · Sponsor
• Sen. Paul, Rand [R-KY] · R · Sponsor
• Sen. Luján, Ben Ray [D-NM] · D · Sponsor
• Sen. Schiff, Adam B. [D-CA] · D · Cosponsor
• · sshr00 · Standing

Related records

• related to ← FDA Modernization Act 3.0