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 20
... months putting together a rather large appli- cation . It can amount to as much as 100,000 pages . In fact , a recent application that was submitted for AZT or Retrovir was 20 linear feet . That application is submitted as a new drug ...
... months putting together a rather large appli- cation . It can amount to as much as 100,000 pages . In fact , a recent application that was submitted for AZT or Retrovir was 20 linear feet . That application is submitted as a new drug ...
Page 33
... months , three to four months , to try to get that information out of the file , because we would have to go drug - by- drug and then look very carefully at what the post - market surveil- lance study was for and exactly what were the ...
... months , three to four months , to try to get that information out of the file , because we would have to go drug - by- drug and then look very carefully at what the post - market surveil- lance study was for and exactly what were the ...
Page 34
... month requirement ) , and 95 percent are evaluated within six months . In the innovator drugs , the mean average time of evaluation is about two years or 24 months . So there has been some information brought to my attention of the ...
... month requirement ) , and 95 percent are evaluated within six months . In the innovator drugs , the mean average time of evaluation is about two years or 24 months . So there has been some information brought to my attention of the ...
Page 54
... months of patent protection following the approval of our supplemental NDA based on the Helsinki data . Under these circumstances , the knowledge developed by the Helsinki Study would provide no advantage to its innovator . From the ...
... months of patent protection following the approval of our supplemental NDA based on the Helsinki data . Under these circumstances , the knowledge developed by the Helsinki Study would provide no advantage to its innovator . From the ...
Page 62
... months . Additional work in rats and dogs for 12 months , covers effects in protracted use . Reproduction studies conducted in rats , rabbits and monkeys . Patent Application ( Appl . No. 819,126 ) on Lopid filed with the U.S. Patent ...
... months . Additional work in rats and dogs for 12 months , covers effects in protracted use . Reproduction studies conducted in rats , rabbits and monkeys . Patent Application ( Appl . No. 819,126 ) on Lopid filed with the U.S. Patent ...
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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...