FDA Modernization Act 3.0

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.

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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

• Introduced in House · 6 February 2024 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 6 February 2024

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 6 February 2024

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 6 February 2024

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

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

Sponsors

• Rep. Carter, Earl L. "Buddy" [R-GA-1] · R · Sponsor
• Rep. Barragán, Nanette Diaz [D-CA-44] · D · Sponsor
• Rep. Harshbarger, Diana [R-TN-1] · R · Sponsor
• Rep. Buchanan, Vern [R-FL-16] · R · Sponsor
• Rep. Carter, Troy A. [D-LA-2] · D · Sponsor
• Rep. Waltz, Michael [R-FL-6] · R · Sponsor
• Rep. DeLauro, Rosa L. [D-CT-3] · D · Sponsor
• Rep. Nehls, Troy E. [R-TX-22] · R · Sponsor
• Rep. Gooden, Lance [R-TX-5] · R · Sponsor
• Rep. Crenshaw, Dan [R-TX-2] · R · Sponsor
• Rep. Fitzpatrick, Brian K. [R-PA-1] · R · Sponsor
• Rep. Valadao, David G. [R-CA-22] · R · Cosponsor
• Rep. Neguse, Joe [D-CO-2] · D · Cosponsor
• Rep. Bilirakis, Gus M. [R-FL-12] · R · Cosponsor
• Rep. Davis, Donald G. [D-NC-1] · D · Cosponsor
• Rep. Gottheimer, Josh [D-NJ-5] · D · Cosponsor
• Del. Norton, Eleanor Holmes [D-DC-At Large] · D · Cosponsor
• Rep. Goldman, Daniel S. [D-NY-10] · D · Cosponsor
• Rep. Ross, Deborah K. [D-NC-2] · D · Cosponsor
• Rep. Pettersen, Brittany [D-CO-7] · D · Cosponsor
• Rep. Lofgren, Zoe [D-CA-18] · D · Cosponsor
• Rep. Titus, Dina [D-NV-1] · D · Cosponsor
• Rep. Lawler, Michael [R-NY-17] · R · Cosponsor
• Rep. Obernolte, Jay [R-CA-23] · R · Cosponsor
• Rep. Tlaib, Rashida [D-MI-12] · D · Cosponsor
• Rep. Burchett, Tim [R-TN-2] · R · Cosponsor
• Rep. Smith, Christopher H. [R-NJ-4] · R · Cosponsor
• Rep. Mace, Nancy [R-SC-1] · R · Cosponsor
• Rep. Fitzgerald, Scott [R-WI-5] · R · Cosponsor
• Rep. Bacon, Don [R-NE-2] · R · Cosponsor
• Rep. Mullin, Kevin [D-CA-15] · D · Cosponsor
• Rep. Cárdenas, Tony [D-CA-29] · D · Cosponsor
• Rep. Carey, Mike [R-OH-15] · R · Cosponsor
• Rep. García, Jesús G. "Chuy" [D-IL-4] · D · Cosponsor
• Rep. Frankel, Lois [D-FL-22] · D · Cosponsor
• Rep. Chu, Judy [D-CA-28] · D · Cosponsor
• Rep. Scholten, Hillary J. [D-MI-3] · D · Cosponsor
• Rep. Crow, Jason [D-CO-6] · D · Cosponsor
• Rep. D'Esposito, Anthony [R-NY-4] · R · Cosponsor
• Rep. Garbarino, Andrew R. [R-NY-2] · R · Cosponsor
• Rep. Harder, Josh [D-CA-9] · D · Cosponsor
• Rep. Nadler, Jerrold [D-NY-12] · D · Cosponsor
• Rep. Lee, Susie [D-NV-3] · D · Cosponsor
• Rep. Tenney, Claudia [R-NY-24] · R · Cosponsor
• Rep. Calvert, Ken [R-CA-41] · R · Cosponsor
• Rep. Doggett, Lloyd [D-TX-37] · D · Cosponsor
• Rep. Malliotakis, Nicole [R-NY-11] · R · Cosponsor
• · hsif00 · Standing

Related records

• related to ← FDA Modernization Act 3.0