Lopid Patent Term Restoration and Fairness Act of 1987: Hearing Before the Subcommittee on Courts, Civil Liberties, and the Administration of Justice of the Committee on the Judiciary, House of Representatives, One Hundredth Congress, First Session, October 8, 1987, Volume 4U.S. Government Printing Office, 1988 - 350 pages |
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Page 19
... safety and effectiveness of the drug for its intended use . In making this determination , we do not consider economic factors or matters relating to the patent laws . I am particularly pleased to have my colleague from the Patent and ...
... safety and effectiveness of the drug for its intended use . In making this determination , we do not consider economic factors or matters relating to the patent laws . I am particularly pleased to have my colleague from the Patent and ...
Page 20
... safety ; Phase II where one enlarges the number of patients that are under study , usually a hundred to two hundred patients , and begins to look at effectiveness in addition to safety and concen- trates on the dose used . After that ...
... safety ; Phase II where one enlarges the number of patients that are under study , usually a hundred to two hundred patients , and begins to look at effectiveness in addition to safety and concen- trates on the dose used . After that ...
Page 21
... safety and for efficacy , and there was a reference to the Finnish study that was designed to provide these answers . I should possibly provide one bit of clarification that is of interest in lipid - lowering drugs . One always looks ...
... safety and for efficacy , and there was a reference to the Finnish study that was designed to provide these answers . I should possibly provide one bit of clarification that is of interest in lipid - lowering drugs . One always looks ...
Page 24
... safety and effectiveness of the drug for its intended use . In making this determination , we do not consider economic factors or matters relating to the patent laws . Although we supported the enactment of the 1984 patent extension law ...
... safety and effectiveness of the drug for its intended use . In making this determination , we do not consider economic factors or matters relating to the patent laws . Although we supported the enactment of the 1984 patent extension law ...
Page 25
... safety . In the case of Lopid , we were particularly concerned because Lopid is chemically related to another drug that was found to have excess mortality in a World Health Organization clinical trial . Because this excess mortality ...
... safety . In the case of Lopid , we were particularly concerned because Lopid is chemically related to another drug that was found to have excess mortality in a World Health Organization clinical trial . Because this excess mortality ...
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Common terms and phrases
apolipoprotein Association atherosclerosis baseline bill blood Capsules cardiovascular cent Chairman changes cholesterol cholesterol levels cholestyramine clofibrate Committee concentrations coronary heart disease decrease diabetic diet dose Drug Administration dyslipidaemic effect of gemfibrozil elevated fatty acid composition FDA approval Finland follow-up Food and Drug Framingham gemfibrozil treatment glucose HDL-cholesterol Health heart attacks Helsinki Heart Study hypercholesterolaemia hypertension incidence increase ischaemic heart disease Journal KASTENMEIER Kaukola laboratory legislation lipid lowering Lipid Research Clinics lipid-lowering lipoprotein cholesterol lipoprotein lipase lipoprotein lipase activity Lithell long-term Lopid Lopid patent low density lipoprotein LRC-CPPT male Manninen market exclusivity metabolism mmol/l mortality myocardial infarction Parke-Davis patent extension patent term extension patients pharmaceutical Phase IV study placebo Primary Prevention Trial ratio reduction regulatory risk factors Royal Society safety serum cholesterol serum lipid significant Society of Medicine Subcommittee Table Term Restoration Act therapy treatment groups triglycerides Vessby VLDL Warner-Lambert Waxman-Hatch
Popular passages
Page 113 - A simplified method for the estimation of total cholesterol in serum and demonstration of its specificity, J.
Page 113 - Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial Results, II: the relationship of reduction in incidence of coronary heart disease to cholesterol lowering.
Page 291 - Kagan A.: Serum lipoproteins and coronary heart disease in a population study of Hawaii Japanese men.
Page 73 - I am a partner in the Washington, DC law firm of Covington & Burling. I have been asked to present testimony on patent term restoration.
Page 341 - Five-year findings of the Hypertension Detection and Followup Program. I. Reduction in mortality of persons with high blood pressure, including mild hypertension.
Page 244 - For the purposes of paragraph (2)(B), the term "due diligence" means that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period.
Page 67 - HL-07182 from the National Heart, Lung and Blood Institute of the National Institutes of Health, and by the American Heart Association, Indiana Affiliate, Inc.
Page 8 - Mr. BOUCHER. Thank you very much, Mr. Chairman. I want to commend you...