 | United States - 1964 - 1098 páginas
...drug, evaluated together with the evidence available to him when the application was approved, that there is a lack of substantial evidence that the drug...the conditions of use prescribed, recommended, or suggested in the labeling thereof; or (4) that the application contains any untrue statement of a material... | |
 | United States - 1977 - 1276 páginas
...drug, evaluated together with the evidence available to him •when the application was approved, that there is a lack of substantial evidence that the drug...the conditions of use prescribed, recommended, or suggested in the labeling thereof; or (4) that the application contains any untrue statement of a material... | |
 | 1981 - 1252 páginas
...to the drug, evaluated together with the evidence available when the application was approved, that there is a lack of substantial evidence that the drug...the conditions of use prescribed, recommended, or suggested in the labeling thereof (the provisions of § 314.111(a)(5) apply to the meaning of "substantial... | |
 | 1977 - 568 páginas
...(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... | |
 | 1974 - 402 páginas
...(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... | |
 | 1982 - 900 páginas
...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... | |
 | 1993 - 640 páginas
...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... | |
 | 1969 - 668 páginas
...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...recommended, or suggested in the proposed labeling; or (6) Based on a fair evaluation of all material facts, such labeling is false or misleading in any... | |
 | 1999 - 596 páginas
...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... | |
 | 1988 - 772 páginas
...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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... 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 labeling or proposed labeling thereof. 
