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SENATE 660116th CongressRead twice and referred to the Committee on Health, Education, Labor, and Pensions.

Efficiency and Transparency in Petitions Act

Last Action
3/5/2019

CRS Summary

As of 2019-03-05 (00)

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 on Congress.gov

Sourced from Congress.gov (public domain).

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.