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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... "
Competitive problems in the drug industry: hearings before Subcommittee on ... - Page 10807
by 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
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Compilation of Selected Public Health Laws, Prepared for the Use of the ...

United States. Congress. House Interstate and Foreign Commerce - 1973 - 162 pages
...subsection (e), 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...
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Agriculture-environmental and Consumer Protection Appropriations for ..., Part 6

United States. Congress. Senate. Appropriations Committee - 1974
...makers claimed it could do. The 1962 Amendments precisely defined "substantial evidence" 33 follows: "Substantial Evidence means evidence consisting 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 effect it purports...
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Psychotropic Substances Act of 1973: Hearing Before the Subcommittee to ...

United States. Congress. Senate. Committee on the Judiciary - 1974 - 543 pages
...supported by "substantial evidence" defined to mean "evidence consisting of adequate and well-controlled investigations, Including clinical investigations,...the drug involved, on the basis of which it could be fairly and responsibly concluded by such experts that the drug will have the effect it purports or...
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Use of Advisory Committees by the Food and Drug Administration: Hearings ...

United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - Citizens' advisory committees in science - 1974
...The Act defines "substantial evidence" 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 effect it purports...
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Use of Advisory Committees by the Food and Drug Administration: Hearings ...

United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee - 1974
...The Act defines "substantial evidence" 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 t concluded by such experts that the drug will have the effect it purports...
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United States Reports: Cases Adjudged in the Supreme Court, Volume 412

United States. Supreme Court - Courts - 1974
...(e) . . . , 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...
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Medical Devices: Hearings, Ninety-third Congress, First Session ...

United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment - Medical instruments and apparatus - 1974 - 446 pages
...subsection (c), 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...
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Agriculture--environmental and Consumer Protection Appropriations for 1975 ...

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture--Environmental and Consumer Protection Appropriations - United States - 1974
...adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the...effectiveness of the drug involved, on the basis of which It ccrald fairly and reasonably IKJ concluded by such experts that the drug will have the effect It purports...
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Agriculture--environmental and Consumer Protection Appropriations for 1975 ...

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture--Environmental and Consumer Protection Appropriations - United States - 1974
...investigations, eluding clinical investigations, by experts qualified by scientific training and perience to evaluate the effectiveness of the drug involved, on the basis of whU it could fairly and responsibly be concluded by such experts that the drug have the effect it purports...
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Regulation of Diethylstilbestrol (DES), 1975: Joint Hearing Before the ...

United States. Congress. Senate. Committee on Labor and Public Welfare - 1975 - 304 pages
...application may be refused unless it includes 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...
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