...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...

...to the drug, evaluated together with the evidence available 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 (the provisions of § 314.111(a)(5) apply to the meaning of "substantial...

...(5) There is a lack of substantial evidence based upon adequate and well-controlled investigations that the drug will have the effect it purports or...recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled investigation must satisfy the following criteria : (i> A clear statement...

...(5) There is a lack of substantial evidence based upon adequate and well-controlled investigations that the drug will have the effect it purports or...recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled investigation must satisfy the following criteria : (i) A clear statement...

...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...recommended, or suggested in the proposed labeling; or (6) Based on a fair evaluation of all material facts, such labeling is false or misleading in any...

...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...recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period of years and are recognized by the...

...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...recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period of years and are recognized by the...

...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...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (6) Failure to include an appropriate proposed...

...such drug evaluated together with the evidence available when the application was approved show that there is a lack of substantial evidence that the drug...the conditions of use prescribed, recommended, or suggested in the labeling thereof, in that: New evidence concerning the clinical investigations of...

...effectiveness. Also, after October 10, 1964, we may withdraw approval of a new drug application if "there is a lack of substantial evidence that the...the effect it purports or is represented to have" (from sec. 505 (e) of the Food, Drug, and Cosmetic Act). THE RISK Dramatic advances in medical science...