...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 labelingthereoL - DRUG SAFETY ¿1271 Mr. Fovirrm¿. LMd you have...

...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. 137 21 USC § 355(c) and (d) (1972). See also...

...insufficient information to determine whether such drug is safe for use under such conditions; or (5) there is a lack of substantial evidence that the drug...the effect it purports or is represented to have; or (6) such labeling is false or misleading in any particular; he shall issue an order refusing to...

...may, however, be withdrawn for any such drug if there is a lack of substantial evidence, as defined, that the drug will have the effect it purports or...under the conditions of use prescribed, recommended, orsuggsst.d in the labeling Where an application for approval of a new drug is pending baler. the Secietary...

...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) the patent information prescribed by subsection (c) was not...

...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. Because no drug is absolutely safe or always...

...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 basis of which it could fairly and responsibly be concluded by such experts that the drug wijl have the effect it purports or is represented to have...recommended, or suggested in the proposed labeling. c. Reports of all clinical tests sponsored by the applicant or received or otherwise obtained by the...

...effectiveness of the drug, 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, the Secretary may find that the evidence for...

...of the drug involved, on the basis of which it could fairly and responsibly be concluded by 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. Section 505, 21 USC 355(d)(1976) (emphasis...