To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
- Bill Number
- H.R. 1843
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-03-05: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-02-05T17:34:06Z
Official 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
Cosponsors (1)
Recent Actions
- 2025-03-05: Referred to the House Committee on Energy and Commerce.
- 2025-03-05: Introduced in House
- 2025-03-05: Introduced in House
Bill Versions
- To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. — issued 2025-03-05 — PDF (4 pages)