S. 660 · 116th Congress

Efficiency and Transparency in Petitions Act

Stage
In committee
Sponsor
Mike Braun
Introduced
2019-03-05
Latest action
2019-03-05 · Introduced in Senate

Summary

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.