Animal Drug Amendments of 1965, Hearing Before the Subcommittee on Public Health and Welfare ... 89-2, on H.R. 7655, H.R. 7797, H.R. 7815, H.R. 8377, H.R. 9542, June 13, 1966, Serial No. 89-36

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Page 5 - As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of 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 or is represented to have under the conditions of use prescribed,...
Page 3 - ... a full list of the articles used as components of such drug; (c) a full statement of the composition of such drug; (d) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing and packing of such drug...
Page 2 - Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That...
Page 4 - ... upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions...
Page 10 - Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug...
Page 9 - Any drug the composition of which is such that such drug, as a result of investigations to determine its safety...
Page 4 - That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal...
Page 75 - An Act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adequately tested to establish their safety", and for other purposes.
Page 6 - Secretary's order. (i) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.
Page 19 - ... worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, are hereby prohibited. The Secretary of Agriculture...

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