...As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and wellcontrolled...drug involved, on the basis of which it could fairly TITLE 21.— POOD AND DRUGS Page 1142 and responsibly be concluded by such experts that the drug will...

...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...

...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,...

...substantial evidence of effectiveness be prorlded and that: . . . tie term "substantial evlovoce" mean* evidence consisting of adequate and well-controlled...evaluate the effectiveness of the drug involved, on the bails of which it could fairly and responsibly be concluded by inch expert* that the drug will have...

...REVISED AUGUST 1963) As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled...responsibly be concluded by such experts that the drug wil! have the effect it purports or is represented to have under the conditions of USP prescribed,...

...REVISED AUGUST 1963) As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled...the drug involved, on the basis of which it could fnirly and responsibly he concluded by such experts that the drug will have the effect it purports...

...other information before the Food and Drug Administration with respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled...training and experience to evaluate the effectiveness of tho drug involved, on the basis of which it could fairly and responsibly he concluded by such experts...

...history of anaphylactic *As defined in the 1!)62 Drug Amendments, "the term 'substantial evidence' means evidence consisting of adequate and well-controlled...the basis of which It could fairly and responsibly he concluded by such experts. that the drug will have the effect It purports or is represented to have...

...adequate and well-controlled investigations, including clinical inTestigations, by experts qualified by scientific training and experience to evaluate the...responsibly be concluded by such experts that the drug would have the effect it purports or is represented to have under the conditions of use prescribed,...

...follows: The term "substantial evidence" means evidence consisting of adequate and well controlled investigations, including clinical investigations...of the drug involved on the basis of which it could be responsibly concluded by such experts that the drug would have the effect that purports to or is...