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Modernizing Therapeutic Equivalence Rating Determination Act

USA117th CongressS-1463| Senate 
| Updated: 4/29/2021
Bill Cassidy

Bill Cassidy

Republican Senator

Louisiana

Cosponsors (1)
Tina Smith (Democratic)

Health, Education, Labor, and Pensions 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
Introduced in Senate
Apr 29, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Apr 5, 2022

Latest Companion Bill Action

HR 117-7377
Referred to the Subcommittee on Health.
  • April 29, 2021
    Introduced in Senate


  • April 29, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • April 5, 2022

    Latest Companion Bill Action

    HR 117-7377
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 117-7377: Modernizing Therapeutic Equivalence Rating Determination Act
Administrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archivesPrescription drugs

Modernizing Therapeutic Equivalence Rating Determination Act

USA117th CongressS-1463| Senate 
| Updated: 4/29/2021
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
Introduced in Senate
Apr 29, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Apr 5, 2022

Latest Companion Bill Action

HR 117-7377
Referred to the Subcommittee on Health.
  • April 29, 2021
    Introduced in Senate


  • April 29, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • April 5, 2022

    Latest Companion Bill Action

    HR 117-7377
    Referred to the Subcommittee on Health.
Bill Cassidy

Bill Cassidy

Republican Senator

Louisiana

Cosponsors (1)
Tina Smith (Democratic)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 117-7377: Modernizing Therapeutic Equivalence Rating Determination Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archivesPrescription drugs