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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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Health and the Environment Miscellaneous: Hearings Before the ..., Part 1

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment - Drugs - 1982
...part: "* * * 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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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1985
...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 effect it purports...
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The Code of Federal Regulations of the United States of America

Administrative law - 1985
...well-controlled investigations, including clinical investigations, by experts qualified by scientilic 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 triāt the Food and Drug Administration, HHS drug...
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Clinical Trials: Design, Conduct, and Analysis

Curtis L. Meinert, Susan Tonascia - Medical - 1986 - 469 pages
...investigations." The term "substantial evidence " means 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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FDA Proposals to Permit the Use of Disease-specific Health Claims on Food ...

United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee - Cancer - 1988 - 471 pages
...defined in section 505(d) of the Act to Include "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 Misuse Among the Elderly and Its Impact on Community-based Care ...

United States. Congress. House. Select Committee on Aging. Subcommittee on Human Services - Aged - 1989 - 601 pages
...the Federal Food, Drug, and Cosmetic Act as "evidence consisting of adequate and well -control led investigations by experts qualified by scientific...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 Misuse Among the Elderly and Its Impact on Community-based Care ...

United States. Congress. House. Select Committee on Aging. Subcommittee on Human Services - Aged - 1989 - 601 pages
...adequate and well-controlled investigations by experts qualified by scientific training and exparience to evaluate the effectiveness of the drug involved, on the basis of which 1t could. fairly and responsibly be concluded by such experts that the drug will have the effect it...
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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
...well-contrslled investigations, including clinical investigations, by experts qualified by sci«istific 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 that the drug will have the affect it purports...
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Problems with FDA's Regulation of the Antiarrhythmic Drugs ..., Volume 4

United States, United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee - Arrhythmia - 1992 - 327 pages
...including clinical 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 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 Committee on ...

United States, United States. Congress. House. Committee on Energy and Commerce - Drugs - 1993 - 459 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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