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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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Federal Food, Drug, and Cosmetic Act, As Amended

DIANE Publishing Company - 1994 - 223 pages
...subsection (e), 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 - 1994
...and well-controlled investigations, including clinical (field) investigation, by experts qualified by scientific training and experience to evaluate the...effectiveness of the drug involved, on the basis of which it couli fairly and reasonably be concluded by such experts that the drug will have the effect it purports...
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Validation Compliance Annual: 1995

International Validation Forum - Science - 1995 - 1200 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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Validation Compliance Biannual 1996-1997

International Validation Forum - Science - 1996 - 856 pages
...subsection (e), 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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Vitamania: Vitamins in American Culture

Rima Apple, Rima Dombrow Apple - Science - 1996 - 245 pages
...experts: "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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Acceptable Risks: Politics, Policy, and Risky Technologies

C. F. Larry Heimann - Political Science - 2010 - 208 pages
...defined substantial evidence of safety and efficacy to be consisting of adequate and well,controlled investigations, including clinical investigations,...the drug involved. on the basis of which it could be fairly and responsibly concluded by such experts that the drug will have the effect it purports or...
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The Ethics of Medical Research on Humans

Claire Foster - Medical - 2001 - 159 pages
...it purports'. 'Substantial evidence' is denned in the Act as follows: 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 Pharmaceutical Industry: Access and Outlook

Ethan N. Parvis - Business & Economics - 2002 - 193 pages
...FDCA defines "substantial evidence" 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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Antiepileptic Drugs

René H. Levy - Medical - 2002 - 968 pages
...Center for Drug Evaluation and Research, United States Food and Drug Administration, Washington, DC by scientific training and experience to evaluate the...the drug involved, on the basis of which it could be fairly and responsibly concluded by such experts that the drug will have the effect it purports or...
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Pharmacoethics: A Problem-Based Approach

David A. Gettman, Dean Arneson - Medical - 2003 - 472 pages
...Substantial evidence is defined in the act as follows: 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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