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
... triglycerides . In our review of the clinical studies , we concluded that our general requirements for demonstrating an effect in re- ducing triglycerides were met , but they did not meet all of the re- quirements for lowering ...
... triglycerides . In our review of the clinical studies , we concluded that our general requirements for demonstrating an effect in re- ducing triglycerides were met , but they did not meet all of the re- quirements for lowering ...
Page 20
... triglycerides and the lowering of cholesterol itself . Mr. KASTENMEIER . Dr. Young , it might be a good point to inter- rupt , since there was reference first in the presentation to Phase IV testing . To an uneducated panel could you ...
... triglycerides and the lowering of cholesterol itself . Mr. KASTENMEIER . Dr. Young , it might be a good point to inter- rupt , since there was reference first in the presentation to Phase IV testing . To an uneducated panel could you ...
Page 21
... triglycerides going down , serum cholesterol going down , but then to make that leap into the effect on patients usually requires a larger study . In more contemporary terms , you see that contro- versy being played out in the case of ...
... triglycerides going down , serum cholesterol going down , but then to make that leap into the effect on patients usually requires a larger study . In more contemporary terms , you see that contro- versy being played out in the case of ...
Page 25
... triglycerides . Based on our review of the NDA , the clinical studies met our general requirements for demonstrating an effect in reducing triglycerides , but did not meet all our requirements for lowering cholesterol . Thus , the ...
... triglycerides . Based on our review of the NDA , the clinical studies met our general requirements for demonstrating an effect in reducing triglycerides , but did not meet all our requirements for lowering cholesterol . Thus , the ...
Page 39
... triglycerides , a change of lowering cholesterol . There was a nagging question in the Agency : Does that change in and of itself indicate a decrease in morbidity and mortality ? That was the reason for the Agency focusing in general on ...
... triglycerides , a change of lowering cholesterol . There was a nagging question in the Agency : Does that change in and of itself indicate a decrease in morbidity and mortality ? That was the reason for the Agency focusing in general on ...
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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...