 | 1981 - 1252 pages
...adequately insure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...concluded by such experts that the drug will have the effectiveness it purports and is represented to have under the conditions prescribed, recommended or... | |
 | 1978 - 860 pages
...adequately Insure safety and efficacy of use. Substantial evidence” has been defined by Congress to mean “evidence consisting of adequate and well-controlled...responsibly be concluded by such experts that the drug vill have the effectiveness It purports and is represented to have under the conditions prescribed,... | |
 | United States. Congress. Senate. Government Operations - 1962 - 1078 pages
...l>y scientific training and ence to evaluate the effectiveness of the drug involved, on the basis of could fairly and respon-sibly be concluded by such experts that the drug trif/ *IK the effect it purports, or is represented to have under the conditions of utf prescribed,... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 844 pages
...1964, we may withdraw approval of a new drug application if "there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have" (from sec. 505 (e) of the Food, Drug, and Cosmetic Act). THE RISK Dramatic advances in medical science... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 1600 pages
...scientific training and I^rience to evaluate the effectiveness of the drug involved, on the basis of lich it could fairly and responsibly be concluded by such experts that the )!£ will have the effect it purports or is represented to have under the Qditions of use prescribed,... | |
 | 1966 - 2114 pages
...Investigations, bj experts qualified by scientific training and experience to evaluate the effectiveness ol the drug Involved, on the basis of which It could...concluded by such experts that the drug will have the Sect It purports or Is represented to have nder the conditions of use prescribed, recmmended, or suggested... | |
 | Raymond F. Clapp - 1966 - 102 pages
...now on, before "new drugs" are approved for marketing, it must be shown, by "substantial evidence," that the drug will have the effect it purports or is represented to have. The burden is on the manufacturer to make this showing. (Hitherto, only clearance for safetv was required,... | |
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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... 
