A bill to address abuse of the Food and Drug Administration's citizen petition process by brand drug manufacturers.
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.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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