Bill Detail
H.R. 1843
Congress: 119
Title
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Summary
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.
Sponsor
Rep. Neal Dunn [R-FL-2]
Status
Referred to the House Committee on Energy and Commerce.
Status as of Aug 1, 2:37 AM · synced 13d ago
Introduced
2025-03-05
Data source mode: congress-gov
Bill Engagement
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…
Lobbyists on the case
- Chamber of Commerce of the U.S.A.1 filing · 32 lobs
- Caroline Billman2025 Q1
- Neil Bradley2025 Q1
Prepared intelligence brief
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