Legis Daily

Prompt Approval of Safe Generic Drugs Act

USA117th CongressHR-2831| House 
| Updated: 4/27/2021
Nanette Diaz Barragán

Nanette Diaz Barragán

Democratic Representative

California

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Prompt Approval of Safe Generic Drugs Act This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a drug even if the drug's labeling lacks certain safety information. Specifically, an abbreviated application for approval of a generic drug shall not be ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's exclusivity protections. Similarly, a drug that is approved under this bill shall not be considered mislabeled for lacking such safety information. Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug. For any drug approved under this bill, the FDA shall require the drug's labeling to include any safety information that is necessary to assure safe use.
View Full Text

Suggested Questions

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

Timeline
Apr 26, 2021
Introduced in House
Apr 26, 2021
Referred to the House Committee on Energy and Commerce.
Apr 27, 2021
Referred to the Subcommittee on Health.
  • April 26, 2021
    Introduced in House


  • April 26, 2021
    Referred to the House Committee on Energy and Commerce.


  • April 27, 2021
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 117-8588: Fair Care Act of 2022
Drug safety, medical device, and laboratory regulationMarketing and advertising

Prompt Approval of Safe Generic Drugs Act

USA117th CongressHR-2831| House 
| Updated: 4/27/2021
Prompt Approval of Safe Generic Drugs Act This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a drug even if the drug's labeling lacks certain safety information. Specifically, an abbreviated application for approval of a generic drug shall not be ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's exclusivity protections. Similarly, a drug that is approved under this bill shall not be considered mislabeled for lacking such safety information. Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug. For any drug approved under this bill, the FDA shall require the drug's labeling to include any safety information that is necessary to assure safe use.
View Full Text

Suggested Questions

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

Timeline
Apr 26, 2021
Introduced in House
Apr 26, 2021
Referred to the House Committee on Energy and Commerce.
Apr 27, 2021
Referred to the Subcommittee on Health.
  • April 26, 2021
    Introduced in House


  • April 26, 2021
    Referred to the House Committee on Energy and Commerce.


  • April 27, 2021
    Referred to the Subcommittee on Health.
Nanette Diaz Barragán

Nanette Diaz Barragán

Democratic Representative

California

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 117-8588: Fair Care Act of 2022
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationMarketing and advertising