 | United States - Law - 1964 - 1098 pages
...any other information before him with respect to such drug, 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 proposed labeling thereof; or (6) based on a fair evaluation of all material facts,... | |
 | United States - Law - 1977 - 1276 pages
...any other information before him with respect to such drug, 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 proposed labeling thereof; (F) upon the basis of the information submitted to him... | |
 | Administrative law - 2002 - 628 pages
...training and experience to evaluate the effectiveness of the new animal drug involved that the new animal drug will have the effect it purPorts or is represented...suggested in the labeling or proposed labeling thereof. Substantial evidence shall include such adeluate and well-controlled studies that are, as a matter... | |
 | Administrative law - 2000 - 698 pages
...training and experience to evaluate the effectiveness of the new animal drug involved that the new animal drug will have the effect it purports or Is represented...suggested in the labeling or proposed labeling thereof. Substantial evidence shall include such adequate and well-controlled studies that are, as a matter... | |
 | Administrative law - 1981 - 1252 pages
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have...the conditions of use prescribed, recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period... | |
 | 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...prescribed, recommended, or suggested in the labeling thereof; or (4) That the application contains any untrue statement of a material fact; or (c) The Commissioner... | |
 | 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...prescribed, recommended, or suggested in the labeling thereof. (4) That any nonclinical laboratory study contained in the application was not conducted in... | |
 | 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...prescribed, recommended, or suggested in the labeling thereof. (4) That any nonclinical laboratory study that is described in the application and that is... | |
 | 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...the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled investigation must satisfy... | |
 | 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...the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled investigation must satisfy... | |
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... that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling... 
