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United States · Bill · HR

H.R. 7248 (118th)

FDA Modernization Act 3.0

referredUnited States· United States Congress· EN

Introduced

6 February 2024

Last action

9 February 2024 · Referred

Status

Referred to the Subcommittee on Health.

Sponsors

Rep. Carter, Earl L. "Buddy" [R-GA-1], Rep. Barragán, Nanette Diaz [D-CA-44], Rep. Harshbarger, Diana [R-TN-1], Vern Buchanan, Rep. Carter, Troy A. [D-LA-2], Michael Waltz, Rosa DeLauro, Troy Nehls, Lance Gooden, Dan Crenshaw, Rep. Fitzpatrick, Brian K. [R-PA-1], David Valadao, Rep. Neguse, Joe [D-CO-2], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Davis, Donald G. [D-NC-1], Rep. Gottheimer, Josh [D-NJ-5], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Goldman, Daniel S. [D-NY-10], Rep. Ross, Deborah K. [D-NC-2], Rep. Pettersen, Brittany [D-CO-7], Zoe Lofgren, Rep. Titus, Dina [D-NV-1], Rep. Lawler, Michael [R-NY-17], Jay Obernolte, Rep. Tlaib, Rashida [D-MI-12], Tim Burchett, Christopher Smith, Nancy Mace, Scott Fitzgerald, Don Bacon, Rep. Mullin, Kevin [D-CA-15], Tony Cárdenas, Rep. Carey, Mike [R-OH-15], Jesús García, Rep. Frankel, Lois [D-FL-22], Rep. Chu, Judy [D-CA-28], Hillary Scholten, Rep. Crow, Jason [D-CO-6], Anthony D'Esposito, Rep. Garbarino, Andrew R. [R-NY-2], Josh Harder, Rep. Nadler, Jerrold [D-NY-12], Rep. Lee, Susie [D-NV-3], Rep. Tenney, Claudia [R-NY-24], Ken Calvert, Rep. Doggett, Lloyd [D-TX-37], Rep. Malliotakis, Nicole [R-NY-11]

Subjects

Healthcare

Source updated

27 May 2025

Healthcare

Official sourceDownload fileView documentsShare

Summary

FDA Modernization Act 3.0 This bill requires the Food and Drug Administration (FDA) to establish a process that supports nonclinical testing methods for drug development that do not involve the use of animals. Specifically, the FDA must establish a pathway by which entities may apply to have nonclinical testing methods approved for use in a particular context. Qualifying methods must be intended to replace or reduce animal testing and to either improve the safety and efficacy of nonclinical testing or reduce the time to develop a drug. The FDA must issue its decision within 180 days of receiving an application. The FDA must also prioritize the review of applications for drugs that are developed using an approved nonclinical testing method. The FDA must annually post a report on its website that summarizes the results of the bill's implementation, including the number of applications received, types of methods that were approved, and the estimated number of animals saved as result of these methods.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 6 February 2024

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  2. 6 February 2024

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 6 February 2024

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 9 February 2024

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

Votes

No vote records are attached yet.

Versions

Documents

3 official files

Introduced in House (text)

View fileDownload file

Sponsors

Related records

Sources

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