...following definition of the term "substantial evidence" : "[T]he term 'substantial evidence' means evidence consisting of adequate and well-controlled...investigations, including clinical investigations, by experts quaillied by scientific training and experience to evaluate the effectiveness of the drug involved,...

...EDWARDS. Substantial evidence of efficacy. Senator NELSON*. The term "substantial evidence" means : Evidence consisting of adequate and well-controlled...training and experience to evaluate the effectiveness of tbe drugs involved, on the basis of which it could fairly and responsibly he concluded by such experts...

...application. " (2) As used in this subsection and subsection (e) , the term 'substantial evidence' means evidence consisting of adequate and well-controlled...and experience to evaluate the effectiveness of the device involved, on the basis of which it could fairly and responsibly be concluded by such experts...

...review was transferred to the courts of appeals. 21 USC §355(h). 3 "Substantial evidence" was defined to mean "evidence consisting of adequate and well-controlled...training and experience to evaluate the effectiveness 01 {he drug involved, on the basis of which it could fairly and responsibly be concluded by such experts...

...subsection and subsection (e) , the 12 term 'substantial evidence' means evidence consisting of ade13 quate and well-controlled investigations, including clinical...and experience to evaluate the effectiveness of the device inifi volved, on the basis of which it could fairly and responsibly 1 7 be concluded by such...

...for use as suggested in the labeling. 0. An application may be refused unless it includes substantial evidence consisting of adequate and wellcontrolled...investigations, by experts qualified by scientific training and experience to evaluate the effective tic aa of the drag involved, on the basis of which it could fairly...

...study. In that regard, the FDA requires : "An application may be refused unless it includes substantial evidence consisting of adequate and well-controlled...investigations by experts qualified by scientific training and experience to evaluate the fffectlTeness of the drug involved, on the basis of which it could fairly...

...or suggested In the proposed labeling thereof" (21 USC 355(d><3)>. Such substantial evidence means "evidence consisting of adequate and well-controlled...Including clinical Investigations, by experts Qualified by Bclenttfle training and experience to evaluate the effectiveness of the drug Involved, on the baste...

...Panel), strongly support retention of the effectiveness requirement. Subsection (b) defines the term "substantial evidence" to mean evidence consisting...investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the effectiveness...

...the information available to It Is insufficient for a determination that the drug Is safe for пае, FDA is also required to refuse approval of the NDA...adequate and well-controlled Investigations, Including cllnicnl Investigations, by expert» qualified by scientific training and ex|wrleuce to evaluate the...