 | James Beck, Anthony Vale - Actions and defenses - 2004 - 982 pages
...442 US 544, 546-548, 99 S.Ct. 2470, 61 L.Ed.2d 68 (1979) (discussing definition) 9 The FDA requires "adequate and well-controlled investigations, including...investigations, by experts qualified by scientific training and experience" to evaluate a drug. 21 USC ยง 355(d). Uncontrolled or partially controlled studies, and... | |
 | Administrative law - 1966 - 696 pages
...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... | |
 | Administrative law - 1967 - 412 pages
...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... | |
 | Administrative law - 1968 - 416 pages
...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... | |
 | 67 pages
...have the effect it purports or is represented to have, " where "substantial evidence" is defined as "evidence consisting of adequate and wellcontrolled...investigations, by experts qualified by scientific 49 training and experience to evaluate the effectiveness of the drug involved, on the basis of which... | |
| |
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 evaulate... 
