 | United States - Law - 1977 - 1276 pages
...qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on thé 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 to have under the conditions of use prescribed,... | |
 | Administrative law - 2000 - 698 pages
...by scientific training and experience to evaluate the effectiveness of the new animal drug involved that the new animal drug will have the effect it purports...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. Substantial evidence shall include such adequate... | |
 | Administrative law - 1988 - 772 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...the conditions of use prescribed, recommended, or suggested in the labeling thereof. (4) That any nonclinical laboratory study that is described in the... | |
 | Administrative law - 1977 - 1080 pages
...available when the application was approved, that 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 labeling thereof (the provisions of § 314.111 (a) (5) apply to the meaning of "substantial... | |
 | Administrative law - 1999 - 596 pages
...studies 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 reasonably 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,... | |
 | Administrative law - 1989 - 764 pages
...investigation, 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 reasonably 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,... | |
 | Administrative law - 1987 - 996 pages
...consisting of adequate and wellcontrolled investigations, as defined in § 314.126, that the drug product will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in its proposed labeling. (6) The proposed labeling is false or misleading in any particular.... | |
 | Administrative law - 1992 - 744 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 Food and Drug Administration, HHS use prescribed, recommended, or suggested in the labeling thereof.... | |
 | Administrative law - 1994 - 1074 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 prescribed, recommended, or suggested in the labeling or proposed labeling there§314.420 of." This... | |
 | 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." This def-inition... | |
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... 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. 
