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Modernizing Therapeutic Equivalence Rating Determination Act

USA117th CongressHR-7377| House 
| Updated: 4/5/2022
John R. Curtis

John R. Curtis

Republican Representative

Utah

Cosponsors (1)
Angie Craig (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Modernizing Therapeutic Equivalence Rating Determination Act This bill requires the Food and Drug Administration (FDA) to provide a therapeutic equivalence rating for certain new drug applications if the applicant requests such a rating. Upon request in the application, the FDA must provide such a rating for a new drug application that relies on information from studies not conducted by the applicant and that the applicant does not have a right to reference or use (commonly referred to as a 505(b)(2) application). The FDA must provide the rating no later than 30 days after the application's approval. (A drug is a therapeutic equivalent of another if they produce the same clinical effect and have the same safety profile. Typically, for certain generic drugs, the FDA rates the therapeutic equivalence of that generic drug to another drug, such as the brand name version. Currently, an applicant seeking approval of a drug through a 505(b)(2) application typically only receives an equivalence rating by requesting one from the FDA in a separate petition.)
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Timeline
Apr 29, 2021

Latest Companion Bill Action

S 117-1463
Introduced in Senate
Apr 4, 2022
Introduced in House
Apr 4, 2022
Referred to the House Committee on Energy and Commerce.
Apr 5, 2022
Referred to the Subcommittee on Health.
  • April 29, 2021

    Latest Companion Bill Action

    S 117-1463
    Introduced in Senate


  • April 4, 2022
    Introduced in House


  • April 4, 2022
    Referred to the House Committee on Energy and Commerce.


  • April 5, 2022
    Referred to the Subcommittee on Health.

Health

Related Bills

  • S 117-1463: Modernizing Therapeutic Equivalence Rating Determination Act

Modernizing Therapeutic Equivalence Rating Determination Act

USA117th CongressHR-7377| House 
| Updated: 4/5/2022
Modernizing Therapeutic Equivalence Rating Determination Act This bill requires the Food and Drug Administration (FDA) to provide a therapeutic equivalence rating for certain new drug applications if the applicant requests such a rating. Upon request in the application, the FDA must provide such a rating for a new drug application that relies on information from studies not conducted by the applicant and that the applicant does not have a right to reference or use (commonly referred to as a 505(b)(2) application). The FDA must provide the rating no later than 30 days after the application's approval. (A drug is a therapeutic equivalent of another if they produce the same clinical effect and have the same safety profile. Typically, for certain generic drugs, the FDA rates the therapeutic equivalence of that generic drug to another drug, such as the brand name version. Currently, an applicant seeking approval of a drug through a 505(b)(2) application typically only receives an equivalence rating by requesting one from the FDA in a separate petition.)
View Full Text

Suggested Questions

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

Timeline
Apr 29, 2021

Latest Companion Bill Action

S 117-1463
Introduced in Senate
Apr 4, 2022
Introduced in House
Apr 4, 2022
Referred to the House Committee on Energy and Commerce.
Apr 5, 2022
Referred to the Subcommittee on Health.
  • April 29, 2021

    Latest Companion Bill Action

    S 117-1463
    Introduced in Senate


  • April 4, 2022
    Introduced in House


  • April 4, 2022
    Referred to the House Committee on Energy and Commerce.


  • April 5, 2022
    Referred to the Subcommittee on Health.
John R. Curtis

John R. Curtis

Republican Representative

Utah

Cosponsors (1)
Angie Craig (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 117-1463: Modernizing Therapeutic Equivalence Rating Determination Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted