| Cosmetics - 1979 - 1418 pages
...“substantial eviden¿ means evidence consistin¿r of adepia*e and well-controlled in¿-estigations, including clinical investigations, by experts qualified...and experience to evaluate the effectiveness of the arug involved, on the basis of ¿ihkh it could fairly and responsibly be concluded by such experts... | |
| Cosmetics - 1979 - 840 pages
...Administration. b. An .application may be Incomplete or may be refused unless it include* substantial evidence consisting of adequate and well-controlled...Investigations, by experts qualified by scientific training and experience to evaluate tbe effectiveness of the drug involved, on the basis of which it could fairly... | |
| Cosmetics - 1979 - 1068 pages
...August 1963, US SS ¿j ¿ j¿ ¿ subsection andsubsection (e), the term ‘substanUal evidence' means evidence consisting of adequate and well-controlled...including cLinical Investigations, by experts qualified by eclentiSe training and experience to evaluate the effectiveness of -the drug involved, on the basf¿... | |
| Cosmetics - 1979 - 1000 pages
...the application. As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled...including clinical investigations, by experts qualified bv scientific training and experience to evaluate the effectiveness of the drug involved, on the basis... | |
| Cosmetics - 1979 - 968 pages
...application. 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 quMlfied by scientific training and experience to evaluate the effectiveness of the drug involved,... | |
| Administrative law - 1985 - 976 pages
...information before the Food and Drug Administration with respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled...including clinical investigations, by experts qualified by scientilic training and experience to evaluate the effectiveness of the drug involved, on the basis... | |
| Kenneth L. Davis, American College of Neuropsychopharmacology - Medical - 2002 - 1964 pages
...offered the following definition of substantial evidence: . . . the term "substantial evidence" means evidence consisting of adequate and well-controlled...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... | |
| René H. Levy - Medical - 2002 - 1000 pages
...for the conditions described in approved product labeling. The Act defines substantial evidence as: ...evidence consisting of adequate and well-controlled...including clinical investigations, by experts qualified Russell Katz, MD: Division of Neuropharmacological Drug Products Center for Drug Evaluation and Research,... | |
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