 | United States - 1964 - Страниц: 1098
...an order approving the application. As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting...drug involved, on the basis of which it could fairly TITLE 21.— POOD AND DRUGS Page 1142 and responsibly be concluded by such experts that the drug will... | |
 | United States - 1977 - Страниц: 1276
...findings upon which it is based. (3) As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting...adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the effectiveness... | |
 | 1979 - Страниц: 1056
...adequately insure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...and responsibly be concluded by such experts that il\e drug will have the effectiveness it purports and is represented to have under the conditions prescribed,... | |
 | 1969 - Страниц: 668
...information before the Food and Drug Administration with respect to such drug, there Is lack of substantial evidence consisting of adequate and well-controlled...training and experience to evaluate the effectiveness §130.13 of the drug involved, on the basis of which it could fairly and responsibly be concluded by... | |
 | 1996 - Страниц: 618
...and well-controlled investigations, including clinical (field) investigation, by experts qualified by scientific training and experience to evaluate the...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 is represented... | |
 | 1980 - Страниц: 684
...and well-controlled investigations, including clinical (field) investigation, by experts qualified by scientific training and experience to evaluate the...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 is represented... | |
 | 1967 - Страниц: 406
...effectiveness of drugs; or (2) For which there exists substantial evidence of safety and effectiveness, consisting of adequate and well-controlled investigations,...investigations, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of the drug involved, on the basis of which it... | |
 | 1965 - Страниц: 1520
...information before the Food and Drug Administration with respect to such drug, there Is lack of substantial evidence consisting of adequate and well-controlled...investigations, by experts qualified by scientific training ar.d experience to evaluate the effectiveness of the drug involved, on the basis of which it could... | |
 | United States. Congress. Senate. Government Operations - 1962 - Страниц: 1078
...substantial evidence of effectiveness be prorlded and that: . . . tie term "substantial evlovoce" mean* evidence consisting of adequate and well-controlled...evaluate the effectiveness of the drug involved, on the bails of which it could fairly and responsibly be concluded by inch expert* that the drug will have... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - Страниц: 650
...the term "substantial evidence" of efficacy means evidence consisting of adequate and well-controlled investigations by experts qualified by scientific...to evaluate the effectiveness of the drug involved. Please let me reiterate my gratitude for your help in this matter. Sincerely yours, JOSEPH F. SADUSK,... | |
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As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and wellcontrolled investigations, including clinical investigations, by experts qualified by scientific training and... 
