A bill to amend the Federal Food, Drug, and Cosmetic Act to establish a standard for determining substantial evidence of a drug's effectiveness for purposes of revocation of an approval of a new drug application under section 505 or repeal of a certification of antibiotics under section 507.

referredUnited States· United States Congress· EN

Introduced

2 October 1973

Last action

—

Status

Referred to House Committee on Interstate and Foreign Commerce.

Summary

Establishes, under the Federal Food, Drug, and Cosmetic Act, a standard for determining substantial evidence of a drug's effectiveness for purposes of revocation of an approval of a new drug application under such Act, or repeal of a certification of antibiotics under such Act. (Amends 21 U.S.C. 355)

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Documents

1 official file

Introduced in House
summary · EN · 2 October 1973
Open at official source

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Sources

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Official source: https://www.congress.gov/bill/93rd-congress/house-bill/10629
Open data entity: https://api.congress.gov/v3/bill/93/hr/10629