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H.R. 3839 118th Congress House

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

Introduced: June 6, 2023 Introduced by: Neal P. Dunn Republican · Florida See on congress.gov
Health Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationPrescription drugs
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This bill died when the 118th Congress ended
It never became law before the 118th Congress (2023–2024) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 9, 2023
Referred to the Subcommittee on Health.
Jun 6, 2023
Referred to the House Committee on Energy and Commerce.
Jun 6, 2023
Introduced in House
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 Latest action June 9, 2023

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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.

 Related & companion bills 4
  • HR 3561 PATIENT Act of 2023
  • S 775 Increasing Transparency in Generic Drug Applications Act
  • S 1114 Expanding Access to Low-Cost Generics Act of 2023
  • HR 5378 Lower Costs, More Transparency Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Lobbying activity 26

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

Bodies those filers lobbied

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APA
U.S. Congress. (2026). H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.. 118th Congress. Open America. https://openamerica.io/bill/118-HR-3839/
MLA
"H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-HR-3839/.
Bluebook (legal)
H.R. 3839, 118th Cong. (2026), https://openamerica.io/bill/118-HR-3839/.
Markdown link
[H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.](https://openamerica.io/bill/118-HR-3839/)
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