Competitive problems in the drug industry: hearings before Subcommittee on Monopoly and Anticompetitive Activities of the Select Committee on Small Business, United States Senate, Ninetieth Congress, first session ... |
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abnormalities acetohexamide American Diabetes Association baseline biguanide blood glucose blood sugar Bradley bread calories carbohydrate cardiac cardiovascular deaths cardiovascular disease cardiovascular mortality cent Chalmers chlorpropamide clinical trials cohort committee conclusions controversy CORNFIELD coronary criteria Crout cyclic AMP death rates diabetes mellitus diabetic patients diabetologists diet dosage dose Drug Administration effect evaluation excess findings Food and Drug glyburide grams Group Diabetes Program hypoglycemic drugs increased indicated inotropic ISTD Joslin Clinic Klimt labeling levels long-term maturity-onset meat Medicine Metabolic myocardial infarction number of patients obesity occur onset oral agents oral drugs oral hypoglycemic agents Orinase percent phenformin physicians placebo placebo group PLBO population prescribed problem risk factors scientific SELTZER Senator NELSON significant statement statistical Table tests therapeutic tion tolazamide TOLB tolbutamide tolbutamide group treatment groups UGDP investigators UGDP study University Group Diabetes Upjohn variable vascular complications vascular disease warning
Popular passages
Page 10792 - Autobiography, sadly remarked that "a new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die, and a new generation grows up that is familiar with it.
Page 10971 - false advertisement" means an advertisement, other than labeling, which is misleading in a material respect; and in determining whether any advertisement is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, sound, or any combination thereof, but also the extent to which the advertisement...
Page 11257 - A corporation may be sued in any judicial district in which it is incorporated or licensed to do business or is doing business, and such judicial district shall be regarded as the residence of such corporation for venue purposes.
Page 10972 - Section 502 (f) of the act provides that a drug shall be deemed to be misbranded : "Unless it labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application. In such manner and form, as are necessary for the protection of users...
Page 11024 - I wish to thank you, Mr. Chairman and members of this committee, for the opportunity to appear before you...
Page 10805 - 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 10855 - DIRECTOR, NATIONAL INSTITUTE OF ARTHRITIS, METABOLISM, AND DIGESTIVE DISEASES, NATIONAL INSTITUTES OF HEALTH; FRANK E.
Page 11256 - For the purposes of this section and section 1441 of this title, a corporation shall be deemed a citizen of any State by which it has been Incorporated and of the State where it has its principal place of business...
Page 10971 - ... 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 10972 - Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users: Provided, That where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health,...