S. 1462 · 117th Congress
Simplifying the Generic Drug Application Process Act
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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CassidySponsor1 cosponsor · 1 D
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill removes a requirement for a generic drug maker to, in some instances, petition the Food and Drug Administration (FDA) before seeking market approval for a generic drug.
What it does: CRS summary · Introduced in Senate · Apr 29, 2021
Simplifying the Generic Drug Application Process Act
This bill removes a requirement for a generic drug maker to, in some instances, petition the Food and Drug Administration (FDA) before seeking market approval for a generic drug.
Currently, if an applicant wishes to submit an abbreviated application (i.e., the type of application typically used to get market approval for a generic drug) for a drug that has a different dosage form or strength from an already-approved drug, the applicant must first petition the FDA for permission to submit the application. Under this bill, an applicant is no longer required to petition the FDA for permission in these instances.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Simplifying the Generic Drug Application Process Act
Latest action (Apr 29, 2021): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Apr 29, 2021
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.