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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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 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
 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.

 Committees of jurisdiction 2