 | United States - 1977 - 1276 pages
...As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and well-controlled...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 pages
...effectiveness of the drug 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 conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) Withdrawal of approval; grounds; immediate... | |
 | 1964 - 1242 pages
...whether such drug is safe for use under such conditions ; or (5) Evaluated on the basis of in formation submitted as part of the application and any other...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... | |
 | 1981 - 1252 pages
...effective for use as suggested in the labeling. b. An application may be refused unless it includes substantial evidence consisting of adequate and well-controlled...recommended, or suggested in the proposed labeling. c. Reports of all clinical tests sponsored by the applicant or received or otherwise obtained by the... | |
 | 1996 - 618 pages
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have...essentials of adequate and well-controlled clinical (field) investigations. They provide the basis for the determination whether there is substantial evidence... | |
 | 1990 - 1086 pages
...adequately ensure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling thereof." This definition... | |
 | 1998 - 1120 pages
...adequately ensure safety and efficacy of use. "Substantial evi-dence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions prescribed, rec-ommended, or suggested in the labeling or proposed labeling thereof." This def-inition... | |
 | 1998 - 1162 pages
...adequately ensure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling thereof." This definition... | |
 | 1965 - 1520 pages
...investigations, including clinical investigations, by experts qualified by scientific training ar.d experience to evaluate the effectiveness of the drug...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... | |
 | 1969 - 668 pages
...investigations, by experts qualified by scientific training and experience to evaluate the effectiveness §130.13 of the drug involved, on the basis of which it could...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... | |
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As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate... 
