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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 10809
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 Acts Within the Jurisdiction of the ..., Volumes 1-2

United States - 1975
...adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the...the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1976
...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...
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Hearings, Reports and Prints of the Senate Select Committee on Small Business

United States. Congress. Senate. Select Committee on Small Business - Legislative hearings - 1977
...met, but there may be some available now. Senator NELSON. The studies require substantial evidence. The term "substantial evidence" means : Evidence consisting...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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Compilation of selected acts within the jurisdiction of the ..., Volume 2

United States - 1977
...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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Impact of Chemical and Related Drug Products and Federal Regulatory ...

United States. Congress. House. Committee on Agriculture. Subcommittee on Dairy and Poultry - Agricultural chemicals - 1977 - 496 pages
...adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the...the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or...
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Hearings, Reports and Prints of the House Committee on Agriculture

United States. Congress. House. Committee on Agriculture - Agricultural laws and legislation - 1977
...adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the...the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or...
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Drug Regulation Reform Act of 1978: Hearings Before the Subcommittee on ...

United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment - Drugs - 1978
...effectiveness": The term "substantial evidence" means evidence consisting of adequate and we 11 -control led 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 1t purports...
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Drug Regulation Reform Act of 1978: Hearings Before the Subcommittee on ...

United States. Congress. Senate. Committee on Human Resources. Subcommittee on Health and Scientific Research - Drugs - 1978 - 1656 pages
..."substantial evidence", and the test for it, as : . . . 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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Hearings, Reports and Prints of the Senate Committee on Human Resources

United States. Congress. Senate. Committee on Human Resources - Human capital - 1978
..."substantial evidence", and the test for it, as : . . . 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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Laetrile, the Commissioner's decision

United States. Food and Drug Administration - Laetrile - 1978 - 73 pages
...sentence of section 505 (d), 21 USC 355(d), as: 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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