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United States · Bill · HR

H.R. 1843 (119th)

To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

referredUnited States· United States Congress· EN

Introduced

5 March 2025

Last action

—

Status

Referred to the House Committee on Energy and Commerce.

Sponsors

—

Subjects

Discovery layer

Source updated

5 February 2026

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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.

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Documents

2 official files

Introduced in House

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Sources

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