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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.

referredUnited States· United States Congress· EN

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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Versions

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Documents

3 official files

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Sources

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