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. 12 September 2024

   Introduced

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

   Source: IntroReferral

2. 12 September 2024

   Introduced

   Introduced in Senate

   Source: IntroReferral

3. 12 December 2024

   Passed

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

   Source: Floor

4. 12 December 2024

   Floor

   Measure laid before Senate by unanimous consent. (consideration: CR S7044)

   Source: Floor

5. 12 December 2024

   Discharge

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

   Source: Discharge

6. 12 December 2024

   Committee

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

   Source: Committee

7. 13 December 2024

   Floor

   Message on Senate action sent to the House.

   Source: Floor

8. 16 December 2024

   Floor

   Held at the desk.

   Source: Floor

9. 16 December 2024

   Floor

   Received in the House.

   Source: Floor

Votes

No vote records are attached yet.

Versions

• Engrossed in Senate · 12 December 2024 · Download file
• Introduced in Senate · 12 September 2024 · Download file

Documents

5 official files

• Engrossed in Senate (text)

  Engrossed in Senate · EN · 12 December 2024

  ViewDownloadOpen at official source

• Engrossed in Senate (PDF)

  Engrossed in Senate · EN · 12 December 2024

  ViewDownloadOpen at official source

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• Passed Senate

  summary · EN · 12 December 2024

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• Introduced in Senate (text)

  Introduced in Senate · EN · 12 September 2024

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 12 September 2024

  ViewDownloadOpen at official source

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  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

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

Related records

• related to → FDA Modernization Act 3.0
• amends ← In the nature of a substitute.