...drug, evaluated together with the evidence available to him when the application was approved, that there is a lack of substantial evidence that the drug...the conditions of use prescribed, recommended, or suggested in the labeling thereof; or (4) that the application contains any untrue statement of a material...

...the drug 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...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. "(e) (1) The Secretary shall, after due notice...

...the drug 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...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. "(e) (1) The Secretary shall, after due notice...

...the drug 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...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. "(e) (1) The Secretary shall, after due notice...

...drugs. Specifically, the Law (FD&C Act, Section 505 (d)) reads: "if the Secretary finds . . . that ... on the basis of the information submitted to him as...recommended, or suggested in the proposed labeling thereof ... he shall issue an order refusing to approve the application ... As used in this subsection and...

...cor.cerr.ir.:; approval or disapproval of any new drug on a fair evaluation of all -.aterial facts that " there is a lack of substantial evidence that the drug...represented to have under the conditions of use prescribed, recor-.T.ended or suggested in the proposed labeling thereofV "Substantial evidence-is defined .by...

...conduction? Are there differences in risk among DPX-containing salts and combinations? 2. Is there "lack of substantial evidence that the drug will have...the conditions of use prescribed, recommended, or suggested in the labeling thereof"? (21 CFR 314.115(b)(3)). Specifically, is there scientific evidence...

...conduction? Are there differences in risk among DPX-containing salts and combinations? 2. Is there "lack of substantial evidence that the drug will have...the conditions of use prescribed, recommended, or suggested in the labeling thereof"? (21 CFR 314.115(b) (3) ). Specifically, is there scientific evidence...

...the drug 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...the conditions of use prescribed, recommended, or suggested in the labeling or proby Alan E. Smith, MD posed labeling thereof." These amendments also...

...the drug 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...under the conditions of use prescribed, recommended or suggested in the labeling or proposed labeling thereof. Now, given the wording of this law, and this...