 | United States - 1977 - 1276 lapas
...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 is represented...the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; (F) upon the basis of the information submitted to him... | |
 | United States - 1964 - 1098 lapas
...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 is represented...the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts,... | |
 | 2001 - 620 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... | |
 | 1986 - 792 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... | |
 | 1981 - 730 lapas
...basis of which it could fairly and reasonably be concluded by such experts that the new animal drug will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the proposed labeling. (iii) An application may be refused unless it contains detailed... | |
 | 1964 - 1242 lapas
...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 is represented...the conditions of use prescribed, recommended, or suggested in the proposed labeling; or (6) Based on a fair evaluation of all material facts, such labeling... | |
 | 1988 - 772 lapas
...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 is represented...the conditions of use prescribed, recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 650 lapas
...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 is represented...prescribed, recommended, or suggested in the labeling or proposed labeling thereof. CLINICAL NEUROPHARMACOLOGY RESEARCH CENTER, NATIONAL INSTITUTE OF MENTAL... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 844 lapas
...involved, on the basis of which it could fairly and responsibly he concluded by such experts that the drug will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the proposed labeling : or ÍO) Rased on a fair evaluation of all material facts, such... | |
 | United States - 1966 - 556 lapas
...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 is represented...the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts,... | |
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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... 
