 | United States - 1977 - Страниц: 1276
...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 purposes of this section and sections... | |
 | United States - 1964 - Страниц: 1098
...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) based on a fair evaluation of all... | |
 | 1964 - Страниц: 1242
...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 on a fair evaluation of all material... | |
 | 1986 - Страниц: 792
...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 laboratory study that is... | |
 | 1981 - Страниц: 730
...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 may be refused unless it contains... | |
 | 1992 - Страниц: 744
...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 Food and Drug Administration, HHS use prescribed, recommended, or suggested in the labeling thereof.... | |
 | 1994 - Страниц: 1074
...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 prescribed, recommended, or suggested in the labeling or proposed labeling there§314.420 of." This... | |
 | 1998 - Страниц: 1120
...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." This def-inition... | |
 | 1998 - Страниц: 1162
...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 prescribed, recommended, or suggested in the labeling or proposed labeling thereof." This definition... | |
 | 1985 - Страниц: 592
...NAS-NRC panels. (b) The indications mentioned in the following categories refer to "the effect the drug purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling." That is, the indications are the claims noted... | |
| |
... 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 basis of which it could fairly and... 
