H.R. 3839
Referred to CommitteeTo amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Introduced 6/6/2023•118th Congress•House
Latest Action
Referred to the Subcommittee on Health.
6/9/2023 • House
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.
Introduced in House • 6/6/2023
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Topics & Subjects
Policy Area: Health
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationPrescription drugs
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Sponsor & Cosponsors (2)
Party Breakdown
1
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1
Republicans
0
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Cosponsors (1)
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Bill Journey
Originated in the House
Introduced
June 6, 2023
Referred to the House Committee on Energy and Commerce.
Committee Review
Floor Debate
Passed Chamber
Other Chamber
President
Enacted into Law
Text Versions (1)
Introduced in House6/6/2023