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.
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Timeline
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health
Administrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archives
Efficiency and Transparency in Petitions Act
USA116th CongressS-660| Senate
| Updated: 3/5/2019
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.
Administrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archives