 | United States - 1977 - 1276 lapas
...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...prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) Withdrawal of approval; grounds; immediate suspension upon finding... | |
 | United States - 1964 - 1098 lapas
...fairly TITLE 21.— POOD AND DRUGS Page 1142 and responsibly be concluded by such experts that the drug will have the effect it purports or is represented...prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) Withdrawal of approval; grounds; immediate suspension upon finding... | |
 | 1977 - 568 lapas
...conditions of use upon the basis of which the application was approved or that section 512 (dKlMH) of the act applies to such drug; or (ill) On the basis...recommended, or suggested in the labeling thereof. (c) The Commissioner may notify in writing the person holding an application approved pursuant to section... | |
 | 1980 - 684 lapas
...conditions of use upon the basis of which the application was approved or that section 512 (d)(IKH) of the act applies to such drug; or (ill) On the basis...recommended, or suggested in the labeling thereof. Title 21 — Food and Drugs (4) That any nonclinical laboratory study contained in the application... | |
 | 1980 - 718 lapas
...the application was approved or that section 512 (dXIXH) of the act applies to such drug; or (iii) On the basis of new information before him with respect...thereof. (4) That any nonclinical laboratory study contained in the application was not conducted in compliance with the good laboratory practice regulations... | |
 | 1981 - 730 lapas
...the application was approved or that section 512 (dXIXH) of the act applies to such drug; or (iii) On the basis of new information before him with respect...or suggested in the labeling thereof. (4) That any none lin irai laboratory study contained in the application was not conducted in compliance with the... | |
 | 1992 - 744 lapas
...the application was approved or that section 512 (d)(l)(H) of the act applies to such drug; or (iii) On the basis of new information before him with respect...or is represented to have under the conditions of Food and Drug Administration, HHS use prescribed, recommended, or suggested in the labeling thereof.... | |
 | 1977 - 1080 lapas
...available 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...recommended, or suggested in the labeling thereof (the provisions of § 314.111 (a) (5) apply to the meaning of "substantial evidence" as used in this... | |
 | 2000 - 698 lapas
...training and 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...prescribed, recommended, or suggested in the labeling or proposed labeling thereof. Substantial evidence shall include such adequate and well-controlled... | |
 | 2002 - 628 lapas
...training and 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...prescribed, recommended, or suggested in the labeling or proposed labeling thereof. Substantial evidence shall include such adeluate and well-controlled... | |
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... evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly... 
