United States · Bill · HR
H.R. 3839 (118th)
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Introduced
6 June 2023
Last action
—
Status
Referred to the Subcommittee on Health.
Sponsors
—
Subjects
Discovery layer
Source updated
24 July 2024
Summary
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.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
No timeline events have been ingested for this record yet.
Votes
No vote records are attached yet.
Versions
No version snapshots stored. Document URLs remain at the source.
Documents
3 official files
Introduced in House (text)
Introduced in House (text)
Introduced in House · EN · 6 June 2023
Introduced in House (PDF)
Introduced in House · EN · 6 June 2023
Introduced in House
summary · EN · 6 June 2023
Sponsors
No sponsors or actors listed by the source.
Related records
No cross-record relationships stored yet.
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/118th-congress/house-bill/3839
- Open data entity: https://api.congress.gov/v3/bill/118/hr/3839