To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
In committee: it can still change before the session ends.
- Stage
- In committee
- Started in
- House
- Sponsors
- 2
- Latest action
- Mar 5, 2025
What it does
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.
Official summary · Introduced in House · Mar 5, 2025
Titles and provisions can change as the bill moves.
Where it stands
Introduced (Done)
Committee (Current step)
Floor (Not started)
Law (Not started)
What moved
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Who is involved
Sponsors
The lawmakers who put their names on it, lead sponsors first.
Where it goes next
While a bill can still move, the questions are about people and money.