 | United States - 1977 - 1276 lapas
...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...the conditions of use prescribed, recommended, or suggested in the labeling of the device, then, for purposes of this section and sections 360d and 360e... | |
 | 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,... | |
 | 1993 - 1052 lapas
...purity, stability, and bioavailability. (2) The investigations required under section 505(b) or 507 of the act do not include adequate tests by all methods...misleading in any particular. (7) The application or abbreviated antibiotic application contains an untrue statement of a material fact. (8) The drug... | |
 | 1994 - 1074 lapas
...safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling1. (3) The results of the tests show that the drug is...misleading in any particular. (7) The application or abbreviated antibiotic application contains an untrue statement of a material fact. (8) The drug... | |
 | 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... | |
 | 1987 - 996 lapas
...well-controlled investigations as defined in § 314.126, that the drug will have the effect it is purported or is represented to have under the conditions of use prescribed, recommended, or suggested in its labeling; or (iv) That the application contains any untrue statement of a material fact. (b) FDA may... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 540 lapas
...scientific training and experience to evaluate the effectiveness of the drug involved, that the drug will have the effect it purports or is represented...of use prescribed, recommended, or suggested in its labeling. 2. The new-drug application contains untrue statements of material fact in that four reports... | |
 | 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. Congress. House. Committee on Interstate and Foreign Commerce - 1966 - 1538 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... | |
| |
... 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... 
