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HR 3839 118th Congress House Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Prescription drugs

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

Introduced: June 6, 2023 Introduced by: Dunn, Neal P. Republican · Florida See on congress.gov
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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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 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.

What's happening now June 9, 2023

Referred to the Subcommittee on Health.

 Related & companion bills 4
  • HR 3561 Related bill PATIENT Act of 2023
  • S 775 Related bill Increasing Transparency in Generic Drug Applications Act
  • S 1114 Related bill Expanding Access to Low-Cost Generics Act of 2023
  • HR 5378 Related bill 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.

See all 26 filings →
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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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