 | 1938 - 1368 pages
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 | California - 1963 - 1282 pages
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 | United States - 1964 - 1098 pages
...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 pages
...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 pages
...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 pages
...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 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... | |
 | 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... | |
 | 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... | |
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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... 
