 | United States. Congress. Senate. Committee on Labor and Public Welfare - 1969 - 1202 lapas
...to him when the application was approved, that there is a lack of substantial evidence that the drug will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the labeling thereof ; or (4) that the application contains any untrue statement of a... | |
 | United States. Congress. Senate. Committee on Labor and Public Welfare - 1969 - 1282 lapas
...involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e)(l) The Secretary shall, after due notice... | |
 | United States - 1970 - 140 lapas
...to him when the application was approved, that there is a lack of substantial evidence that the drug will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the labeling thereof; or (4) that the application contains any untrue statement, of a... | |
 | United States. Congress. House. Committee on Interstate and Foreign Commerce - 1971 - 36 lapas
...to him when the application was approved, that there is a lack of substantial evidence that the drug will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the labeling thereof; or (4) that the application contains &ny untrue statement of a material... | |
 | United States - 1971 - 870 lapas
...him when the application was approved, that there is a lack of substantial evidence that such drug will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the labeling thereof; "(D) that the application contains any untrue statement of a material... | |
 | United States. Congress. House. Interstate and Foreign Commerce - 1971 - 110 lapas
...on the basis of which it could fairly and responsibly be concluded by such experts that the device will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. " (3) For the purposes of this section, when... | |
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... consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and... 
