Hearings, Reports and Prints of the Senate Select Committee on Small Business, Parts 20-22

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Page 8800 - ... representations made or suggested by statement, word, design, device, sound, or any combination thereof, but also the extent to which the advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the commodity to which the advertisement relates under the conditions prescribed in said advertisement, or under such conditions as are customary or usual.
Page 8120 - As used in this subsection and subsection (e), 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, recommended,...
Page 8120 - For which there exists substantial clinical experience (as used in this section this means substantial clinical experience adequately documented in medical literature or by other data (to be supplied to the Food and Drug Administration...
Page 8341 - Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.
Page 8341 - ... a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this act as to safety and has the identity and strength and meets the quality and purity characteristics, which it purports or is represented to possess...
Page 8336 - The effects of drugs vary from patient to patient and from time to time in the same patient.
Page 7972 - ... required both to justify the introduction of any new product and to sustain the continued marketing of products already on the market. Congress decreed that claims of drug effectiveness must be supported by "substantial evidence...
Page 8859 - Part 1 Regulations for the enforcement of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.
Page 8341 - ... direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those com-ponents that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (8) Inactive ingredient means any component other than an active ingredient.
Page 8024 - Stat. 704, 705, amended the act of 1910 to readThat whenever an invention described in and covered by a patent of the United States shall hereafter be used or manufactured by or for the United States...

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