 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...  Competitive problems in the drug industry: hearings before Subcommittee on ... - Page 10805by United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly and Anticompetitive Activities, United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1967 - 15579 pagesFull view - About this book
 | United States. Department of Health, Education, and Welfare - Education - 1970 - 394 pages
...effectiveness be based on * * * substantial evidence . . . consisting of adequate and wellcontrolled investigations, including clinical investigations,...the drug 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... | |
 | 67 pages
...section, the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug 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... | |
 | Administrative law - 1973 - 724 pages
...evidence" has been defined by Congress to mean "evidence consisting of adequate and wen-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effectiveness it purports... | |
 | Administrative law - 1972 - 736 pages
...evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effectiveness it purports... | |
 | 362 pages
...that the drug is both safe and effective: . . . evidence consisting of adequate and wellcontrolled investigations, including clinical investigations,...the drug 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... | |
 | Administrative law - 1973 - 744 pages
...evidence" has been denned by Congress to mean "evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effectiveness it purports... | |
 | Administrative law - 1970 - 654 pages
...respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug 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... | |
 | Administrative law - 1973 - 398 pages
...application may be refused unless It Includes substantial evidence consisting of adequate and well-controlled investigations, Including clinical investigations,...the drug 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... | |
 | Administrative law - 1968 - 636 pages
...unless lt lncludes substantial evidence consisting of adequate and well-controlled lnvestigations, including clinical investigations, by experts qualified...effectiveness of the drug involved, on the basis of which lt could fairly and responsibly be concluded by such experts that the drug will have the effect it... | |
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