...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...the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts,...

...information before him with respect to such drug, there is a lack of substantial evidence that the drug will ^ 6 suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts,...

...experience to evaluate the effectiveness of the new animal drug involved that the new animal drug will have the effect it purports or is represented to have...suggested in the labeling or proposed labeling thereof. Substantial evidence shall include such adequate and well-controlled studies that are, as a matter...

...experience to evaluate the effectiveness of the new animal drug involved that the new animal drug will have the effect it purports or is represented to have...suggested in the labeling or proposed labeling thereof. Substantial evidence shall include such adequate and well-controlled studies that are, as a matter...

...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 to have...prescribed, recommended, or suggested in the labeling thereof (the provisions of § 314.111(a)(5) apply to the meaning of "substantial evidence" as used...

...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...prescribed, recommended, or suggested in the labeling thereof. (4) That any nonclinical laboratory study contained in the application was not conducted in...

...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...the conditions of use prescribed, recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period...

...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 PHS 380.304-2 in...

...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....

...by such experts that the new animal drug will have the effect it Food and Drug Administration, HHS 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 detailed...