 | United States - 1977 - 1276 lapas
...qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on thé basis of which it could fairly and reasonably be concluded...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) Withdrawal of approval; grounds; immediate... | |
 | United States - 1964 - 1098 lapas
...involved, on the basis of which it could fairly TITLE 21.— POOD AND DRUGS Page 1142 and responsibly be concluded by such experts that the drug will have...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) Withdrawal of approval; grounds; immediate... | |
 | 1995 - 616 lapas
...submitted as part of the application and any other information before the Food and Drug Administration with respect to such drug, there is lack of substantial...recommended, or suggested in the proposed labeling. §514.111 (ii) The following principles have been developed over a period of years and are recognized... | |
 | 1999 - 596 lapas
...substantial evidence consisting of one or more adequate and well-controlled studies by experts qualified by scientific training and experience to evaluate the...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (6) Failure to include an appropriate proposed... | |
 | 1977 - 568 lapas
...(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... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 844 lapas
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have...recommended, or suggested in the proposed labeling. c. The complete composition and/or method of manufacture of the new drug used in each submitted report... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 540 lapas
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof." At the request of the Commissioner, the National... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 650 lapas
...evaluate the effectiveness of the drug involved, on the basis of which it could fnirly and responsibly he concluded by such experts that the drug will have...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. Mr. FOUNTAIN. Did you have any other contact... | |
 | United States. Congress. House. Committee on Interstate and Foreign Commerce - 1966 - 1538 lapas
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. "(e) (1) The Secretary shall, after due notice... | |
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... substantial evidence" means 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... 
