To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
119-HR-1843119th CongressIntroduced Mar 5, 2025Health
Market Probability
No market
Status
Introduced
Committee
Floor Vote
Other Chamber
Signed
Referred to the House Committee on Energy and Commerce.
Sponsor
Rep. Dunn, Neal P. [R-FL-2](R-FL-2)1 cosponsor
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.
Actions (3)
Referred to the House Committee on Energy and Commerce.
Mar 5, 2025House floor actions
Introduced in House
Mar 5, 2025Library of Congress
Introduced in House
Mar 5, 2025Library of Congress