...evidence consisting of adequate and wellcontrolled investigations, including clinical investigations, by experts qualified by scientific training and experience...drug involved, on the basis of which it could fairly TITLE 21.— POOD AND DRUGS Page 1142 and responsibly be concluded by such experts that the drug will...

...evidence consisting of adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience...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...

...consisting of adequate and well-controlled investigations, including clinical (field) investigation, by experts qualified by scientific training and experience...the conditions of use prescribed, recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period...

...consisting of adequate and well-controlled investigations, including clinical (field) investigation, by experts qualified by scientific training and experience...the conditions of use prescribed, recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period...

...evidence available when the application was approved, that there is a lack of substantial evidence that the drug will have the effect it purports or...prescribed, recommended, or suggested in the labeling thereof; or (4) That the application contains any untrue statement of a material fact; or (c) The Commissioner...

..."evidence consisting of adequate and well-controlled Investigations, Including clinical Investigations, by experts qualified by scientific training and experience...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...

...evidence consisting of adequate and well-controlled Investigations, including clinical investigations, by experts qualified by scientific training and experience...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...

..."evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience...involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effectiveness it purports and...

...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...

...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 contained in the application was not conducted in...