Prompt Approval of Safe Generic Drugs Act

referredUnited States· United States Congress· EN

Introduced

26 April 2021

Last action

27 April 2021 · Referred

Status

Referred to the Subcommittee on Health.

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

26 April 2021
Introduced
Referred to the House Committee on Energy and Commerce.
Source: IntroReferral
26 April 2021
Introduced
Introduced in House
Source: IntroReferral
26 April 2021
Introduced
Introduced in House
Source: IntroReferral
27 April 2021
Referred
Referred to the Subcommittee on Health.
Source: Committee

Votes

No vote records are attached yet.

Versions

Introduced in House · 26 April 2021 · Download file

Documents

3 official files

Introduced in House (text)

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Introduced in House (text)
Introduced in House · EN · 26 April 2021
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Introduced in House (PDF)
Introduced in House · EN · 26 April 2021
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Introduced in House
summary · EN · 26 April 2021
Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Vertaal naar
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Related records

related to ← Fair Care Act of 2022

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://www.congress.gov/bill/117th-congress/house-bill/2831
Open data entity: https://api.congress.gov/v3/bill/117/hr/2831
us · 117-hr-2831 · source updated 7 April 2025