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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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Postmarketing surveillance of prescription drugs.

...section, 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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The Code of Federal Regulations of the United States of America

Administrative law - 1973
...evidence" has been defined by Congress to mean "evidence consisting of adequate and wen-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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Code of Federal Regulations

Administrative law - 1972
...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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Neurotoxicity : identifying and controlling poisons of the nervous system ...

...that the drug is both safe and effective: . . . 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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Code of Federal Regulations

Administrative law - 1973
...evidence" has been denned 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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FDA Management and Enforcement: Hearing Before the Subcommittee on ..., Volume 4

United States, United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations - Generic drugs - 1992 - 388 pages
...Section 505 states that substantial evidence means "evidence 3or.sisv.ing 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 affect it purports...
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Code of Federal Regulations

Administrative law - 1970
...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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Code of Federal Regulations

Administrative law - 1973
...application may be refused unless It Includes 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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Code of Federal Regulations

Administrative law - 1968
...unless lt lncludes substantial evidence consisting of adequate and well-controlled lnvestigations, including clinical investigations, by experts qualified...effectiveness of the drug involved, on the basis of which lt could fairly and responsibly be concluded by such experts that the drug will have the effect it...
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A Legislative History of the Federal Food, Drug, and Cosmetic Act ..., Volume 23

Cosmetics - 1979
...well-controlled investigations, including field investigation, by experts qualified by scientific training sod experience to evaluate the effectiveness 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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