Kefauver Harris Amendment
The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications.
1962 Food, Drug, and Cosmetics Act AmendmentsAdderallAlma Levant HaydenArthur M. SacklerClomifeneColey's toxinsConjugated estrogensControlled Substances ActCriticism of the Food and Drug AdministrationDirective 65/65/EECDrug Efficacy AmendmentDrug Efficacy Study ImplementationDurham-Humphrey AmendmentEnantioselective synthesisEstes KefauverFederal Food, Drug, and Cosmetic ActFood and Drug AdministrationFrances Oldham KelseyGeorge P. LarrickGuidances for statistics in regulatory affairsHistory of the Food and Drug AdministrationKefauver-Harris AmendmentKefauver-Harris Drug Control ActMetandienoneNew Drug ApplicationNew FrontierOren HarrisOrphan Drug Act of 1983Outline of clinical researchPharmaceutical industryRegulation of scienceRegulatory affairsStanozololThalidomideThalidomide scandalWilliam Coley
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Kefauver Harris Amendment
The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications.
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Enmienda Kefauver Harris fue u ...... tara de nuevo «avance» médico.
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The U.S. Kefauver Harris Amend ...... ew "breakthrough" medications.
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1,025,409,711
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acts amended
cite public law
conferencedate
1962-10-04
effective date
1962-10-10
enacted by
fullname
An act to protect the public h ...... ority; and for other purposes.
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introducedby
Estes Kefauver
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introduceddate
1962-07-19
introducedin
Senate
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name
Drug Amendments of 1962
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nickname
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Drug Efficacy Amendment
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Kefauver Harris Amendment
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passedbody
House
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Senate
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passeddate
1962-08-23
1962-10-04
passedvote
public law url
sections amended
§ 301 et seq.
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signeddate
1962-10-10
signedpresident
title amended
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Enmienda Kefauver Harris fue u ...... tara de nuevo «avance» médico.
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The U.S. Kefauver Harris Amend ...... ew "breakthrough" medications.
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label
Enmienda Kefauver Harris
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Kefauver Harris Amendment
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