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
... agent , if the Food and Drug Administra- tion approves this drug for a second indication . As you know , the drug was originally approved for marketing in 1981 for a narrow indication . In our public health regulatory mission in the ...
... agent , if the Food and Drug Administra- tion approves this drug for a second indication . As you know , the drug was originally approved for marketing in 1981 for a narrow indication . In our public health regulatory mission in the ...
Page 24
... agent , if the Food and Drug Administration ( FDA ) approves this drug for a second indication . The drug was originally approved for marketing in 1981 for a narrow indication . As you know , the FDA is a public health regulatory agency ...
... agent , if the Food and Drug Administration ( FDA ) approves this drug for a second indication . The drug was originally approved for marketing in 1981 for a narrow indication . As you know , the FDA is a public health regulatory agency ...
Page 37
... when these lipid - lowering agents were brought forward . In this particular case , it was in the approvable letter , and an agreement was made by the company to proceed with this Phase IV study , so that there was a much 37.
... when these lipid - lowering agents were brought forward . In this particular case , it was in the approvable letter , and an agreement was made by the company to proceed with this Phase IV study , so that there was a much 37.
Page 38
... agents that we have seen . That is why both of the answers are correct but for different situations . We do not have the ability to go back and check every one of our Phase IV studies , and , therefore , I could not be as absolute in ...
... agents that we have seen . That is why both of the answers are correct but for different situations . We do not have the ability to go back and check every one of our Phase IV studies , and , therefore , I could not be as absolute in ...
Page 41
... agents that you wanted to have more data . I know that is not a very clear answer , but it is the way in which we were trying to struggle through these new classes of lipid - lower- ing agents to try to get a long - term understanding ...
... agents that you wanted to have more data . I know that is not a very clear answer , but it is the way in which we were trying to struggle through these new classes of lipid - lower- ing agents to try to get a long - term understanding ...
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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...