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Increasing Transparency in Generic Drug Applications Act

USA118th CongressS-775| Senate 
| Updated: 3/14/2023
Margaret Wood Hassan

Margaret Wood Hassan

Democratic Senator

New Hampshire

Cosponsors (3)
Mike Braun (Republican)Rand Paul (Republican)John W. Hickenlooper (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Increasing Transparency in Generic Drug Applications Act 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

Bill from Previous Congress

S 117-4338
Increasing Transparency in Generic Drug Applications Act
Mar 14, 2023
Introduced in Senate
Mar 14, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 117-4338
    Increasing Transparency in Generic Drug Applications Act


  • March 14, 2023
    Introduced in Senate


  • March 14, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 118-3561: PATIENT Act of 2023
  • HR 118-5378: Lower Costs, More Transparency Act
  • HR 118-3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
  • 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

Increasing Transparency in Generic Drug Applications Act

USA118th CongressS-775| Senate 
| Updated: 3/14/2023
Increasing Transparency in Generic Drug Applications Act 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

Bill from Previous Congress

S 117-4338
Increasing Transparency in Generic Drug Applications Act
Mar 14, 2023
Introduced in Senate
Mar 14, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 117-4338
    Increasing Transparency in Generic Drug Applications Act


  • March 14, 2023
    Introduced in Senate


  • March 14, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Margaret Wood Hassan

Margaret Wood Hassan

Democratic Senator

New Hampshire

Cosponsors (3)
Mike Braun (Republican)Rand Paul (Republican)John W. Hickenlooper (Democratic)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 118-3561: PATIENT Act of 2023
  • HR 118-5378: Lower Costs, More Transparency Act
  • HR 118-3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
  • 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