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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... "
Use of Advisory Committees by the Food and Drug Administration: Hearings ... - Page 59
by United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - 1974
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The Code of Federal Regulations of the United States of America

Administrative law - 1969
...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 130.13 of the drug involved, on the basis of which it could fairly and responsibly be concluded by...
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Code of Federal Regulations

Administrative law - 1965
...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...
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The Code of Federal Regulations of the United States of America

Administrative law - 1967
...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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Drug Safety: Hearings Before a Subcommittee of the Committee on Government ...

United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 2377 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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Compilation of Selected Public Health Laws, Volume 1

United States - Public health laws - 1966
...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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1966
...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...
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FDA Papers

Consumer protection - 1969
...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...
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Compendium of Medical Advertising, Volume 40

United States. Food and Drug Administration - Advertising - 1967 - 67 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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Competitive problems in the drug industry: hearings before Subcommittee on ...

United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - Pharmaceutical industry - 1967
...effectiveness of drugs ; or (ft) 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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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1968
...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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