 | United States - Law - 1977 - 1276 pages
...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) Withdrawal of approval; grounds; immediate... | |
 | United States - Law - 1964 - 1098 pages
...it could fairly TITLE 21.— POOD AND DRUGS Page 1142 and responsibly be concluded by such experts that the drug will have the effect it purports or...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) Withdrawal of approval; grounds; immediate... | |
 | Administrative law - 1974 - 402 pages
...(5) There is a lack of substantial evidence based upon adequate and well-controlled investigations that the drug will have the effect it purports or...recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled investigation must satisfy the following criteria : (i> A clear statement... | |
 | Administrative law - 1977 - 568 pages
...(5) There is a lack of substantial evidence based upon adequate and well-controlled investigations that the drug will have the effect it purports or...recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled investigation must satisfy the following criteria : (i) A clear statement... | |
 | Administrative law - 1993 - 640 pages
...the drug 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...recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period of years and are recognized by the... | |
 | Administrative law - 1982 - 900 pages
...the drug 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...recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period of years and are recognized by the... | |
 | Administrative law - 1969 - 668 pages
...evidence available when the application was approved, that there is a lack of substantial evidence that the drug will have the effect it purports or...the conditions of use prescribed, recommended, or suggested in the labeling thereof; or (4) That the application contains any untrue statement of a material... | |
 | Administrative law - 1999 - 596 pages
...the drug 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...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (6) Failure to include an appropriate proposed... | |
 | Administrative law - 1980 - 718 pages
...available to him when the application was approved, 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. (4) That any nonclinical laboratory study contained in the application... | |
 | Administrative law - 1988 - 772 pages
...available to him when the application was approved, 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. (4) That any nonclinical laboratory study that is described in the... | |
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... evidence 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... 
