 | Administrative law - 1969 - 668 pages
...information before the Food and Drug Administration with respect to such drug, there Is lack of substantial evidence consisting of adequate and well-controlled...training and experience to evaluate the effectiveness ยง130.13 of the drug involved, on the basis of which it could fairly and responsibly be concluded by... | |
 | Administrative law - 1965 - 1520 pages
...information before the Food and Drug Administration with respect to such drug, there Is lack of substantial evidence consisting of adequate and well-controlled...investigations, by experts qualified by scientific training ar.d experience to evaluate the effectiveness of the drug involved, on the basis of which it could... | |
 | Administrative law - 1967 - 406 pages
...effectiveness of drugs; or (2) For which there exists substantial evidence of safety and effectiveness, consisting of adequate and well-controlled investigations,...investigations, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of the drug involved, on the basis of which it... | |
 | United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 844 pages
...effectiveness of drugs ; or (2) For which there exists substantial evidence of safety and effectiveness consisting of adequate and well-controlled investigations,...investigations, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of the drug involved, on the basis of which it... | |
 | United States - Public health laws - 1966 - 556 pages
...subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-con trolled investigations, including clinical investigations,...training and experience to evaluate the effectiveness 01 the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts... | |
 | Administrative law - 1966 - 2114 pages
...effectiveness of drugs; or (2) For which there exists substantial svidence of safety and effectiveness, consisting of adequate and well-controlled investigations,...investigations, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of the drug involved, on the basis of which it... | |
 | Consumer protection - 1969 - 484 pages
...claims of effectiveness . . . must be supported by substantial evidence," and Congress went on to define "substantial evidence" to mean: "Evidence consisting...training and experience to evaluate the effectiveness FDA Papers \ of the drug involved, on the basis of which it could fairly and responsibly be concluded... | |
 | United States. Food and Drug Administration - Advertising - 1967 - 84 pages
...effectiveness of drugs, or (2) for which there exists substantial evidence of safety and effectiveness, consisting of adequate and well-controlled investigations,...investigations, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of the drug involved, on the basis of which it... | |
 | Administrative law - 1968 - 600 pages
...effectiveness of drugs; or (2) For which there exists substantial evidence of safety and effectiveness, consisting of adequate and well-controlled Investigations,...investigations, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of the drug involved, on the basis of which it... | |
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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 evaulate... 
