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S. 660

Efficiency and Transparency in Petitions Act

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.

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sen. Braun, Mike [R-IN](R-IN)Sponsor
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  1. IntroReferral

    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Health, Education, Labor, and Pensions Committee
  2. IntroReferral10000

    Introduced in Senate

Efficiency and Transparency in Petitions Act — Informed