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HR 2831 117th Congress House Health Drug safety, medical device, and laboratory regulation Marketing and advertising

Prompt Approval of Safe Generic Drugs Act

Introduced: April 26, 2021 Introduced by: Barragán, Nanette Diaz Democratic · California See on congress.gov
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This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) 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
Apr 27, 2021
Referred to the Subcommittee on Health.
Apr 26, 2021
Introduced in House
Apr 26, 2021
Referred to the House Committee on Energy and Commerce.
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 Plain-English summary Congressional Research Service

Prompt Approval of Safe Generic Drugs Act

This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a drug even if the drug's labeling lacks certain safety information.

Specifically, an abbreviated application for approval of a generic drug shall not be ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's exclusivity protections. Similarly, a drug that is approved under this bill shall not be considered mislabeled for lacking such safety information.

Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug.

For any drug approved under this bill, the FDA shall require the drug's labeling to include any safety information that is necessary to assure safe use.

What's happening now April 27, 2021

Referred to the Subcommittee on Health.

 Related & companion bills 1
  • HR 8588 Related bill Fair Care Act of 2022
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 2831: Prompt Approval of Safe Generic Drugs Act. 117th Congress. Open America. https://openamerica.io/bill/117-HR-2831/
MLA
"H.R. 2831: Prompt Approval of Safe Generic Drugs Act." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-HR-2831/.
Bluebook (legal)
H.R. 2831, 117th Cong. (2026), https://openamerica.io/bill/117-HR-2831/.
Markdown link
[H.R. 2831: Prompt Approval of Safe Generic Drugs Act](https://openamerica.io/bill/117-HR-2831/)
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