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" This summary shall fairly show the effectiveness of the drug in the conditions for which it is recommended in the advertisement, together with a showing of those side effects and contraindications that are pertinent with respect to the uses recommended... "
Competitive Problems in the Drug Industry - Page 1446
by United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1968
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Code of Federal Regulations: Containing a Codification of Documents of ...

1965 - 1520 pages
...advertisement that provides any information regarding indications or dosage recommendations. This summary shall fairly show the effectiveness of the drug in the conditions for which it is recommended in the adver^sement, together with a showing of those side effects and contraindications that are pertinent...
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Interagency Coordination in Drug Research and Regulations: Hearings ...

United States. Congress. Senate. Government Operations - 1962 - 1078 pages
...regulations which shall be issued by the Secretary..." f The regulation would require that the brief summary "fairly show the effectiveness of the drug in the conditions for which it is recommended in the advertisement, together with a showing of those side effects and contraindications that are...
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Drug Safety: Hearings Before a Subcommittee of the Committee on Government ...

United States. Congress. House. Committee on Government Operations - 1964 - 844 pages
...present a brief summary of side effects, contraindications and effectiveness. This summary must fnirly show the effectiveness of the drug in the conditions for which it is recommended in the advertisement. It also must show any side effects and contraindications pertinent to the recommended...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1966 - 2114 pages
...advertisement that provides any information regarding indications or dosage recommendations. This summary shall fairly show the effectiveness of the drug in the conditions for which it is recommended in the advertisement, together with a showing of those side effects and contraindications that are...
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FDA Papers, Volume 3

1969 - 454 pages
...lacked fair balance in their presentations on the effectiveness and contraindications of the drug, did not fairly show the effectiveness of the drug in the conditions for which it was recommended in the advertisements, and suggested uses for the drug that were not in the labeling...
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FDA Papers, Volume 1

1967 - 454 pages
...investigational drugs, and required that a New Drug Application must include substantial evidence of the effectiveness of the drug in the conditions for which it is recommended. The efficacy requirement of the 1962 amendments necessitates investigations which are better planned...
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Compendium of Medical Advertising, Volume 40

United States. Food and Drug Administration - 1967 - 84 pages
...regulations require as far as the selling part of the ad is concerned four things : — a fair summary of the effectiveness of the drug in the conditions for which it is offered, along with all of the side effects, contraindications, precautions, and warnings applicable...
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Competitive Problems in the Drug Industry, Parts 8-9

United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1968 - 840 pages
...require — insofar as the selling part of the ad is concerned — four things : A fair summary of the effectiveness of the drug in the conditions for which it is offered, along with all of the side effects, contraindications, precautions, and warnings applicable...
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FDA Papers, Volume 6

1972 - 448 pages
...regulation 21 CFR 1.10S(e) in that the advertisement lacks fair balance in its presentation and does not fairly show the effectiveness of the drug in the...conditions for which it is recommended or suggested in the advertisement since the advertisement represents: 1. That therapy may be initiated parentally and then...
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A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its ...

1979 - 840 pages
...to present a brief summary of side effects, contraindications und effectiveness. This summary must fairly show the effectiveness of the drug in the conditions for which it is recommended In the advertisement. It also must show any side effects and contraindications pertinent to the recommended...
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