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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 10805
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 - 15579 pages
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Federal Trade Commission Decisions, Volume 98

United States. Federal Trade Commission - Competition - 1982 - 988 pages
...evidence" of drug efficacy in Section 505(d) as evidence consisting of adequate and well-controlled investigations, including clinical investigations,...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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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 - 442 pages
...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 - 982 pages
...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 - 976 pages
...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 triât the Food and Drug Administration, HHS drug...
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Clinical Trials: Design, Conduct, and Analysis

Curtis L. Meinert, Susan Tonascia - Clinical trials - 1986 - 502 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 - 494 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 - 620 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 - 612 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. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations - Business & Economics - 1992 - 400 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. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee - Medical - 1992 - 342 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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