...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...

..."Substantial evidence" was specifically denned 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 effect it purports...

...labeling. 2. The term "substantial evidence" means "evidence consisting of adequate and well-controlled investigations, including clinical investigations,...effectiveness of the drug involved, on the basis of which it would fairly and responsibly be concluded by such experts that the drug will have the effect it purports...

...apply, he shall issue an order approving the application. As used in this subsection and subsection (e), 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...

...respect to such drug, there is lack of substantial 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...

...subsection (e), the term 'substantial evidence" means evidence consisting of adequate and well -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 it purports...

...controversy has its roots in the statutory definition of "substantial evidence" for this purpose as meaning evidence consisting of adequate and well controlled...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...

...supported by 'substantial evidence' denned to mean 'evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could be fairly and responsibly concluded by such experts that the drug will have the effect it purports or...

...of its effectiveness. "Substantial evidence" (of effectiveness) means "adequate and well-controlled U k E, | Eӂz c$ z v [ t m yL , L m +o m 22 m...O Wy TB M S W T{t /HL> &0 Уk6 ^f ^ ~ Ֆ5] r@ ;0h8' ˁLJR fairly and responsibly be concluded by «uch experts that the drug will have the effect It purports...

..."substantial evidence." which was defined to mean: . . . 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...