United States · Bill · HR
H.R. 3851 (98th)
A bill to amend the Federal Food, Drug, and Cosmetic Act to remove the prohibition against stating in the labeling and advertising of a drug that it has been approved under that Act.
Introduced
4 August 1983
Last action
—
Status
Received in the Senate and read twice and referred to the Committee on Labor and Human Resources.
Sponsors
—
Subjects
Discovery layer
Source updated
21 April 2025
Summary
Amends the Federal Food, Drug, and Cosmetic Act to permit drug labeling and advertising to note Food and Drug Administration approval. Directs the Secretary of Health and Human Services to promulgate related regulations within one year. Permits a drug with an approved application to include on its label the statement "FDA Approved" followed by the new drug application number. Permits the advertising use of such information.
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Timeline
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Votes
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Versions
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Documents
3 official files
Passed House amended
summary · EN · 8 November 1983
Reported to House with amendment(s)
summary · EN · 21 October 1983
Introduced in House
summary · EN · 4 August 1983
Sponsors
No sponsors or actors listed by the source.
Related records
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Sources
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- Official source: https://www.congress.gov/bill/98th-congress/house-bill/3851
- Open data entity: https://api.congress.gov/v3/bill/98/hr/3851