 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, 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...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... | |
 | DIANE Publishing Company - 1994 - 226 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... | |
 | Administrative law - 1994 - 638 pages
...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... | |
 | International Validation Forum - Science - 1995 - 1114 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... | |
 | International Validation Forum - Science - 1996 - 860 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... | |
 | Rima Dombrow Apple - Health & Fitness - 1996 - 268 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... | |
 | 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... | |
 | Claire Foster - Medical - 2001 - 178 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... | |
 | Ethan N. Parvis - Drugs - 2002 - 214 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... | |
 | René H. Levy - Medical - 2002 - 1000 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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