A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments, Volume 11

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U.S. Department of Health, Education, and Welfare, Public Health Service, Food and Drug Administration, 1979
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Page 120 - ... 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, or suggested in the labeling or proposed labeling...
Page 72 - State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor...
Page 489 - Comp., p. 456), provides in part: (a) The Government shall obtain the entire right, title and interest in and to all inventions made by any Government employee (1) during working hours, or (2) with a contribution by the Government of facilities, equipment, materials, funds, or information, or of time or services of other Government employees on official duty, or (3) which bear a direct relation to or are made in consequence of the official duties of the inventor.
Page 43 - ... a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug...
Page 120 - Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling...
Page 329 - ... he should retain the principal or exclusive rights for a further period of time, the government shall have the right to require the granting of a license to an applicant on a non-exclusive royalty free basis.
Page 44 - Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented...
Page 131 - ... products conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include...
Page 99 - Part 132, that engage in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs...
Page 114 - ... in sufficient detail to permit evaluation of the adequacy of the described methods of manufacture, processing, and packing and the described facilities and controls to determine and preserve the identity, strength, quality, and purity of the drug: a.

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