Competitive problems in the drug industry: hearings before Subcommittee on Monopoly and Anticompetitive Activities of the Select Committee on Small Business, United States Senate, Ninety-first Congress, first session ...

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Page 782 - ... 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...
Page 724 - More detailed professional information available on request. Science for the world's well-being"' PFIZER LABORATORIES Division, Chas. Pfizer & Co., Inc. New York, New York 10017 40 In answering advertisements, please mention The Journal of Bone and Joint Suryery.
Page 724 - However, use of oxytetracycline during tooth development (= last trimester of pregnancy, neonatal period and early childhood) may cause discoloration of the teeth (= yellow-grey-brownish).
Page 801 - 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 486 - ... bill is urgently needed and needed now and this bill should provide for more than a 1-year lease so that a farmer who intends to stay in the tobacco business can equip himself for an efficient operation. I appreciate the opportunity to appear before this committee. Thank you, gentlemen. Mr. ABBITT. We appreciate very much your taking the time to come here and give us the benefit of your views. I assure that at a later time we will go into this matter very seriously that you have presented. Mr....
Page 801 - An advertisement for a prescription drug subject to certification shall not recommend nor suggest any use that is not in the labeling covered by the certification or covered by the applicable certification regulations or regulations providing for exemption from certification. The advertisement shall present information from such labeling covered by the certification, or the applicable certification regulations or regulations providing for exemption from certification, concerning...
Page 782 - ... application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of...
Page 737 - Food and Drug Administration, US Department of Health, Education, and Welfare.
Page 782 - Buildings in which drugs are manufactured, processed, packaged, labeled, or held shall be maintained in a clean and orderly manner and shall be of suitable size, construction, and location in relation to surroundings to facilitate maintenance and operation for their intended purpose. The buildings shall: (a) Provide adequate space for the orderly placement of equipment and materials used in any of the following operations for which...
Page 779 - Components used in the manufacture and processing of drugs, regardless of whether they are intended to appear in the finished product, shall be identified, stored, examined, tested, inventoried, handled, and otherwise controlled in a manner to assure that they conform to appropriate standards of identity, strength, quality, and purity, and are free of contaminants at time of use, and...