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 10805by 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 pagesFull view - About this book
| 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... | |
| 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... | |
| 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... | |
| 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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