H.R. 1843 · 119th Congress
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
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R
DunnSponsor1 cosponsor · 1 D
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.
What it does: CRS summary · Introduced in House · Mar 5, 2025
This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Latest action (Mar 5, 2025): Referred to the House Committee on Energy and Commerce.
Policy area: Health · Origin: House · Introduced: Mar 5, 2025
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.