 | 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
...As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and wellcontrolled...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 drug will... | |
 | 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... | |
 | 1986 - 1610 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... | |
 | 1981 - 1252 pages
...adequately insure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...concluded by such experts that the drug will have the effectiveness it purports and is represented to have under the conditions prescribed, recommended or... | |
 | 1978 - 860 pages
...adequately Insure safety and efficacy of use. Substantial evidence” has been defined by Congress to mean “evidence consisting of adequate and well-controlled...responsibly be concluded by such experts that the drug vill have the effectiveness It purports and is represented to have under the conditions prescribed,... | |
 | 1979 - 1056 pages
...adequately insure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...and responsibly be concluded by such experts that il\e drug will have the effectiveness it purports and is represented to have under the conditions prescribed,... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 844 pages
...submitted by the applicant to the Food and Drug Administration. b. An application may be incomplete or may be refused unless it includes substantial evidence...which it could fairly and responsibly be concluded that the drug will have the effect it purports or is represented to have under the conditions of use... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 1600 pages
...REVISED AUGUST 1963) As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled...responsibly be concluded by such experts that the drug wil! have the effect it purports or is represented to have under the conditions of USP prescribed,... | |
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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... 
