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; and for other purposes.

referredUnited States· United States Congress· EN

Introduced

27 March 1979

Last action

—

Status

Referred to Senate Committee on Labor and 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 a new drug approved for marketing.

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Documents

1 official file

Introduced in Senate
summary · EN · 27 March 1979
Open at official source

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Sources

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Official source: https://www.congress.gov/bill/96th-congress/senate-bill/779
Open data entity: https://api.congress.gov/v3/bill/96/s/779