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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... "
Drug Safety - Page 1258
by United States. Congress. House. Committee on Government Operations - 1964
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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 - 404 pages
...evidence means "evidence cor.si=i.ing of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific...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...
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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 - 476 pages
...adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will...
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Unstable Frontiers: Technomedicine And the Cultural Politics of "Curing" AIDS

194 pages
...evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific...to evaluate the effectiveness of the drug involved. (Cited in ACT UP, 1988, p. 7) Regulatory medicine emerged in conjunction with the rise of corporate...
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Federal Food, Drug, and Cosmetic Act, As Amended

DIANE Publishing Company - 1994 - 226 pages
...evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific...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...
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Food and Drug Administration's Regulation of Dietary Supplements: Hearing ...

United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee - Health & Fitness - 1994 - 530 pages
...investigations (human studies conducted in a controlled clinical setting), by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved. (The statutory term "substantial evidence" should not be confused with the same term used by some comments...
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Alternative Medicine: Expanding Medical Horizons. A Report to the National ...

Alternative medicine - 1994 - 454 pages
..."Substantial evidence" is defined as "adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific...evaluate the effectiveness of the drug involved." Many alternative medical practitioners have attempted to market new drugs or vaccines under this statute,...
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Validation Compliance Annual: 1995

International Validation Forum - Science - 1995 - 1114 pages
...Congress to mean "evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific...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...
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Vitamania: Vitamins in American Culture

Rima Dombrow Apple - Health & Fitness - 1996 - 268 pages
...evidence' means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific...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...
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Validation Compliance Biannual 1996-1997

International Validation Forum - Science - 1996 - 860 pages
...evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific...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...
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Acceptable Risks: Politics, Policy, and Risky Technologies

C. F. Larry Heimann - Political Science - 2010 - 208 pages
...safety and efficacy to be consisting of adequate and well,controlled investigations, including clinical investigations, by experts qualified by scientific...to evaluate the effectiveness of the drug involved. on the basis of which it could be fairly and responsibly concluded by such experts that the drug will...
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