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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 53
by United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - 1974
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A Legislative History of the Federal Food, Drug, and Cosmetic Act ..., Volume 22

Cosmetics - 1979 - 1418 pages
...“substantial eviden¿ means evidence consistin¿r of adepia*e and well-controlled in¿-estigations, including clinical investigations, by experts qualified...and experience to evaluate the effectiveness of the arug involved, on the basis of ¿ihkh it could fairly and responsibly be concluded by such experts...
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A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its ...

Cosmetics - 1979 - 840 pages
...Administration. b. An .application may be Incomplete or may be refused unless it include* substantial evidence consisting of adequate and well-controlled...Investigations, by experts qualified by scientific training and experience to evaluate tbe effectiveness of the drug involved, on the basis of which it could fairly...
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A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its ...

Cosmetics - 1979 - 1068 pages
...August 1963, US SS ¿j ¿ j¿ ¿ subsection andsubsection (e), the term ‘substanUal evidence' means evidence consisting of adequate and well-controlled...including cLinical Investigations, by experts qualified by eclentiSe training and experience to evaluate the effectiveness of -the drug involved, on the basf¿...
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A Legislative History of the Federal Food, Drug, and Cosmetic Act ..., Volume 24

Cosmetics - 1979 - 1000 pages
...the application. As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled...including clinical investigations, by experts qualified bv scientific training and experience to evaluate the effectiveness of the drug involved, on the basis...
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A Legislative History of the Federal Food, Drug, and Cosmetic Act ..., Volume 23

Cosmetics - 1979 - 968 pages
...application. 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 quMlfied by scientific training and experience to evaluate the effectiveness of the drug involved,...
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Chemical Reporting and Record-keeping Authorities Under 15 Environmental and ...

United States. Environmental Protection Agency. Office of Toxic Substances. Chemical Information Division - Chemicals - 1979 - 280 pages
...the application. As used in this subsection and subsection (e) below, "substantial evidence" means evidence consisting of adequate and well-controlled...investigations, including clinical investigations by experts on the basis of which it could fairly and responsibly be concluded by experts that the drug will have...
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The Code of Federal Regulations of the United States of America

Administrative law - 1985 - 976 pages
...information before the Food and Drug Administration with respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled...including clinical investigations, by experts qualified by scientilic training and experience to evaluate the effectiveness of the drug involved, on the basis...
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Problems with FDA's Regulation of the Antiarrhythmic Drugs ..., Volume 4

United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee - Medical - 1992 - 342 pages
...the application. As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled...investigations, by experts qualified by scientific training and experience to evaulate the effectiveness of the drug involved, on the basis of which it could fairly...
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Neuropsychopharmacology: The Fifth Generation of Progress : an Official ...

Kenneth L. Davis, American College of Neuropsychopharmacology - Medical - 2002 - 1964 pages
...offered the following definition of substantial evidence: . . . the term "substantial evidence" means evidence consisting of adequate and well-controlled...training and experience to evaluate the effectiveness the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts...
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Antiepileptic Drugs

René H. Levy - Medical - 2002 - 1000 pages
...for the conditions described in approved product labeling. The Act defines substantial evidence as: ...evidence consisting of adequate and well-controlled...including clinical investigations, by experts qualified Russell Katz, MD: Division of Neuropharmacological Drug Products Center for Drug Evaluation and Research,...
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