...in part, the amendment authorizes the Food and Drug Administration to demand "substantial evidence that the drug will have the effect it purports or...recommended, or suggested in the proposed labeling thereof." in 1970 Congress enacted the Comprehensive Dru9 Abuse Prevention and Control Act 1t replaced...

...including clinical investigations, by experts qualified by scientific training and experience to evaulate the effectiveness of the drug involved, on the basis...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) The Secretary shall, after due notice and...

...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e)(1) The Secretary shall, after due notice...

...the application. As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) The Secretary shall, after due notice and...

..."good science." A section of the Kefauver Amendment reads: If there is a lack of substantial evidence that the drug will have the effect it purports or...recommended or suggested in the proposed labeling thereof . . . [the secretary of health and human services] shall issue an order refusing to approve...

...to approve an application for approval of such a drug where there is a lack of substantial evidence that the drug will . have the effect It purports or...recommended, or suggested in the proposed labeling thereof. Section 505(d) of the act provides further that the term "substantial evidence" means evidence...

...evaluate the effectiveness of the drug involved, on the basis of which it couli fairly and reasonably be concluded by such experts that the drug will have...the conditions of use prescribed, recommended, or suggested IB the proposed labeling. (il) The following principles have been developed over a period...

...adequately ensure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling thereof." This definition...

...manufacturer. Under the Act, the effectiveness determination requires "substantial evidence" that a drug "will have the effect it purports or is represented...recommended, or suggested in the proposed labeling thereof." The Act does not require that the claimed effect represent a benefit to the animal to which...

...delegated evaluation and decision making to scientific experts: "The term 'substantial evidence' means evidence consisting of adequate and well-controlled...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof."" Clearly, Pannett did not have the data to...