HOUSE 3839118th CongressReferred to the Subcommittee on Health.

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

Last Action: 6/9/2023

Actions

2023-06-09Referred to the Subcommittee on Health.
2023-06-06Referred to the House Committee on Energy and Commerce.
2023-06-06Introduced in House
2023-06-06Introduced in House

CRS Summary

As of 2023-06-06 (00)

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.

Cosponsors (1)

Ann Kuster (D-NH)

Subjects

Administrative law and regulatory procedures
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Prescription drugs

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