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Proposal:Efficiency and Transparency in Petitions Act

This proposal is archived and closed to further debate. It was introduced in the 116th Congress, which has concluded, and the bill was not enacted into law.
Geographic Scope
National

Description

Efficiency and Transparency in Petitions Act

This bill requires a petition regarding a pending generic drug or biological product application to be submitted to the Food and Drug Administration (FDA) within one year of when the petitioner discovers the issue that is the basis for the petition.

The FDA may grant a waiver of the one-year deadline.

Bill Title

Efficiency and Transparency in Petitions Act

Linked Goals

Steps

  • 2019-03-05: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • 2019-03-05: Introduced in Senate

Projected Outcome

A more informed proposal or public response aligned with the Promote General Welfare goal.