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 |
From inside the book
Results 1-5 of 42
Page 4
... phase IV clini- cal study that had been requested as a condition for approval has been undertaken , " ( 3 ) the phase IV clinical study has covered at least five years with the study term commencing prior to the introduction of the Drug ...
... phase IV clini- cal study that had been requested as a condition for approval has been undertaken , " ( 3 ) the phase IV clinical study has covered at least five years with the study term commencing prior to the introduction of the Drug ...
Page 9
... Phase IV study which involved providing a basic medical hypothesis concerning cholesterol levels that was at the core of the Lopid development . The problem is that by the time such FDA approval could be given , there will be less than ...
... Phase IV study which involved providing a basic medical hypothesis concerning cholesterol levels that was at the core of the Lopid development . The problem is that by the time such FDA approval could be given , there will be less than ...
Page 10
... Phase IV , as I understand it , is the most expensive study of that nature that has ever been done . They have invested heavily in pioneering drug research and testing and will not have a substantial time in the market after all of the ...
... Phase IV , as I understand it , is the most expensive study of that nature that has ever been done . They have invested heavily in pioneering drug research and testing and will not have a substantial time in the market after all of the ...
Page 12
... Phase IV study which involved proving a basic medical hypothesis , related to cholesterol levels , that was at the core of Lopid's development . It This Phase IV study , the Helsinki Heart Study , has become the longest and most complex ...
... Phase IV study which involved proving a basic medical hypothesis , related to cholesterol levels , that was at the core of Lopid's development . It This Phase IV study , the Helsinki Heart Study , has become the longest and most complex ...
Page 13
... Phase IV health study , and most importantly , it will prove fundamental cardiovascular hypotheses related to cholesterol levels . Third , the 1984 Act undercut the economic assumptions which were at the heart of Warner - Lambert's ...
... Phase IV health study , and most importantly , it will prove fundamental cardiovascular hypotheses related to cholesterol levels . Third , the 1984 Act undercut the economic assumptions which were at the heart of Warner - Lambert's ...
Other editions - View all
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...