A bill to amend the Federal Food, Drug, and Cosmetic Act, as amended, to require the submission of certain additional information by applicants for new drugs; to require the inclusion of certain additional information in drug labeling.

referredUnited States· United States Congress· EN

Introduced

4 February 1977

Last action

—

Status

Referred to Senate Committee on Labor and Public Welfare (Subsequently: Human Resources).

Summary

Amends the Federal Food, Drug, and Cosmetic Act to require a statement of: (1) biological criteria relating to therapeutic effectiveness and safety; and (2) performance data relating to such biological criteria, as part of the application for approval of a new drug under such Act. Requires that such information also be on the labeling of drugs approved for marketing.

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Versions

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Documents

1 official file

Introduced in Senate
summary · EN · 4 February 1977
Open at official source

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Sources

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Official source: https://www.congress.gov/bill/95th-congress/senate-bill/636
Open data entity: https://api.congress.gov/v3/bill/95/s/636