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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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Drug Efficacy: Hearings Before a Subcommittee of the Committee on ..., Part 2

United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - Drugs - 1970
..."Substantial evidence" was specifically denned 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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Drug Efficacy: Hearings Before a Subcommittee of the ..., Volumes 74-77

United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - Drugs - 1970
...labeling. 2. The term "substantial evidence" means "evidence consisting of adequate and well-controlled investigations, including clinical investigations,...effectiveness of the drug involved, on the basis of which it would fairly and responsibly be concluded by such experts that the drug will have the effect it purports...
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Laws Relating to Agriculture

United States - Agricultural laws and legislation - 1971 - 840 pages
...apply, he shall issue an order approving the application. As used in this subsection and subsection (e), 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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The Safety and Effectiveness of New Drugs (standards for ..., Volumes 74-77

United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - Drugs - 1971 - 52 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...
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FDA Regulation of the New Drug "Serc".: Hearing Before a ..., Volumes 74-77

United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - Betahistine - 1972 - 126 pages
...controversy has its roots in the statutory definition of "substantial evidence" for this purpose as meaning evidence consisting of adequate and well controlled...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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FDA Consumer, Volume 10

Consumer protection - 1976
...supported by 'substantial evidence' denned 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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Agriculture--environmental and Consumer Protection Appropriations ..., Part 4

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture--Environmental and Consumer Protection Appropriations - 1972
...of its effectiveness. "Substantial evidence" (of effectiveness) means "adequate and well-controlled U k E, | Eӂz c$ z v [ t m yL , L m +o m 22 m...O Wy TB M S W T{t /HL> &0 Уk6 ^f ^ ~ Ֆ5] r@ ;0h8' ˁLJR fairly and responsibly be concluded by Ğuch experts that the drug will have the effect It purports...
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FDA Consumer, Volume 7

Consumer protection - 1973
..."substantial evidence." which was defined to mean: . . . 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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Agriculture-environmental and Consumer Protection Appropriations for ..., Part 6

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture--Environmental and Consumer Protection Appropriations - United States - 1973
...makers claimed it could do. The 1962 Amendments precisely, defined "substantial evidence" ae 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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Agriculture-environmental and Consumer Protection Appropriations for ..., Part 6

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture--Environmental and Consumer Protection Appropriations - United States - 1973
...makers claimed it could do. The 1962 Amendments precisely, defined "substantial evidence" as 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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