 | United States - Law - 1977 - 1276 pages
...device, and (ii) from which it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device, then, for... | |
 | United States - Law - 1964 - 1098 pages
...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 to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6)... | |
 | Administrative law - 1964 - 1242 pages
...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 to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling; or (6) Based... | |
 | Administrative law - 1986 - 792 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 to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof. (4) That any nonclinical... | |
 | Administrative law - 1998 - 1120 pages
...involved, on the basis of which it could fairly and re-sponsibly be concluded by such experts that the drug will have the effect It purports or is represented to have under the conditions prescribed, rec-ommended, or suggested in the labeling or proposed labeling thereof."... | |
 | Administrative law - 1981 - 730 pages
...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 to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling. (iii) An application... | |
 | United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 844 pages
...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 to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling : or ÍO) Rased... | |
 | United States. Congress. House Interstate and Foreign Commerce - 1966 - 574 pages
...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 to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.... | |
 | United States. Congress. House. Interstate and Foreign Commerce - 1966 - 82 pages
...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 to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof ; "(IT)... | |
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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. 
