...investigations, eluding clinical investigations, by experts qualified by scientific training and perience to evaluate the effectiveness of the drug involved, on the basis of whU it could fairly and responsibly be concluded by such experts that the drug have the effect it purports...

...application may be refused unless it includes substantial evidence consisting of adequate and wellcontrolled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports...

...adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the...the drug 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...

...evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effectiveness it purports...

...met, but there may be some available now. Senator NELSON. The studies require substantial evidence. The term "substantial evidence" means : Evidence consisting...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports...

...subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports...

...adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the...the drug 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...

...adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the...the drug 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...

...effectiveness": The term "substantial evidence" means evidence consisting of adequate and we 11 -control led investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect 1t purports...

..."substantial evidence", and the test for it, as : . . . evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports...