 | United States - 1964 - 1098 lapas
...involved, on the basis of which it could fairly TITLE 21.— POOD AND DRUGS Page 1142 and responsibly be concluded by such experts that the drug will have...suggested in the labeling or proposed labeling thereof. (e) Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to public health.... | |
 | United States - 1977 - 1276 lapas
...available 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...prescribed, recommended, or suggested in the labeling thereof; or (4) that the application contains any untrue statement of a material fact: Provided, That... | |
 | 1999 - 596 lapas
...substantial evidence consisting of one or more adequate and well-controlled studies by experts qualified by scientific training and experience to evaluate the...suggested in the labeling or proposed labeling thereof. (6) Failure to include an appropriate proposed tolerance for residues in edible products derived from... | |
 | 1980 - 718 lapas
...of substantial evidence consisting of adquate and well-controlled investigations, including clinical (field) investigation, by experts qualified by scientific...the conditions of use prescribed, recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period... | |
 | 2002 - 628 lapas
...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... | |
 | 2000 - 698 lapas
...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... | |
 | 1981 - 1252 lapas
...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... | |
 | 1969 - 668 lapas
...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... | |
 | 1988 - 772 lapas
...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... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 540 lapas
...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...suggested in the labeling or proposed labeling thereof." At the request of the Commissioner, the National Academy of Sciences-National Research Council (NAS-XRC)... | |
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... substantial evidence" means 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... 
