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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 10807
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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Medical Use of Marijuana: Policy, Regulatory, and Legal Issues

Tatiana Shohov - Medical - 2003 - 138 pages
..."substantial evidence" which is defined 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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Sample Size Calculations in Clinical Research

Shein-Chung Chow, Hansheng Wang, Jun Shao - Mathematics - 2003 - 358 pages
...Drug and Cosmetics Act in 1962 is defined as the 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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Public Policy and the Economics of Entrepreneurship

Douglas Holtz-Eakin, Harvey S. Rosen - Business & Economics - 2003 - 228 pages
...is defined by section 505(d) of the FD&C Act as "evidence 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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Blood Substitutes

Robert M. Winslow - Science - 2005 - 576 pages
...Winslow. ISBN- 13: 978-0- 12-759760-7 ISBN- 10: 0- 12-759760-3 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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Health and Work Productivity: Making the Business Case for Quality Health Care

Ronald C. Kessler, Paul E. Stang - Business & Economics - 2006 - 306 pages
...means evidence consisting of adequate and well-controlled investigations [defined in 21 CFR 314.126], including clinical investigations, by experts qualified...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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RU-486: Demonstrating a Low Standard for Women's Health? : Hearing ..., Volume 4

United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources - Abortifacients - 2007 - 632 pages
...3S5(d) ("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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Formative Acts: American Politics in the Making

Pelatiah Perit Professor of Political and Social Science Stephen Skowronek, Stephen Skowronek, Matthew Glassman - Political Science - 2007 - 444 pages
...or may be refused unless it includes substantial evidence consisting of adequate and well-controlled investigations, by experts qualified by scientific...the drug involved, on the basis of which it could fairly and responsibly be concluded that the drug will have the effect it purports or is represented...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1964
...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 - 1971
...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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Annual Report

United States. Dept. of Health, Education, and Welfare - Education - 1970
...effectiveness be based on * * * substantial 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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