To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

Summary

This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.

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

Timeline

1. 6 June 2023

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 6 June 2023

   Introduced

   Introduced in House

   Source: IntroReferral

3. 6 June 2023

   Introduced

   Introduced in House

   Source: IntroReferral

4. 9 June 2023

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 6 June 2023 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 6 June 2023

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 6 June 2023

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 6 June 2023

  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. Dunn, Neal P. [R-FL-2] · R · Sponsor
• Rep. Kuster, Ann M. [D-NH-2] · D · Sponsor
• · hsif00 · Standing

Related records

• related to → PATIENT Act of 2023
• related to → Increasing Transparency in Generic Drug Applications Act
• related to → Expanding Access to Low-Cost Generics Act of 2023
• related to ← Lower Costs, More Transparency Act