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

USA118th CongressHR-3839| House 
| Updated: 6/9/2023
Neal P. Dunn

Neal P. Dunn

Republican Representative

Florida

Cosponsors (1)
Ann M. Kuster (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Jun 6, 2023
Introduced in House
Jun 6, 2023
Referred to the House Committee on Energy and Commerce.
Jun 9, 2023
Referred to the Subcommittee on Health.
  • June 6, 2023
    Introduced in House


  • June 6, 2023
    Referred to the House Committee on Energy and Commerce.


  • June 9, 2023
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 118-3561: PATIENT Act of 2023
  • S 118-775: Increasing Transparency in Generic Drug Applications Act
  • HR 118-5378: Lower Costs, More Transparency Act
  • S 118-1114: Expanding Access to Low-Cost Generics Act of 2023
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationPrescription drugs

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

USA118th CongressHR-3839| House 
| Updated: 6/9/2023
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jun 6, 2023
Introduced in House
Jun 6, 2023
Referred to the House Committee on Energy and Commerce.
Jun 9, 2023
Referred to the Subcommittee on Health.
  • June 6, 2023
    Introduced in House


  • June 6, 2023
    Referred to the House Committee on Energy and Commerce.


  • June 9, 2023
    Referred to the Subcommittee on Health.
Neal P. Dunn

Neal P. Dunn

Republican Representative

Florida

Cosponsors (1)
Ann M. Kuster (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 118-3561: PATIENT Act of 2023
  • S 118-775: Increasing Transparency in Generic Drug Applications Act
  • HR 118-5378: Lower Costs, More Transparency Act
  • S 118-1114: Expanding Access to Low-Cost Generics Act of 2023
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationPrescription drugs