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

referredUnited States· United States Congress· EN

Introduced

24 March 1975

Last action

—

Status

Referred to Senate Committee on Labor and Public Welfare.

Summary

Requires, under the Federal Food, Drug, and Cosemtic Act, applicants for new drugs to submit a statement of biological criteria relating to therapeutic effectiveness and safety which the applicant claims should be specially considered by practitioners who dispense such drug. States that a drug shall be deemed to be mislabeled unless its label contains a statement of biological criteria and performance data.

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Documents

1 official file

Introduced in Senate
summary · EN · 24 March 1975
Open at official source

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Sources

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Official source: https://www.congress.gov/bill/94th-congress/senate-bill/1317
Open data entity: https://api.congress.gov/v3/bill/94/s/1317