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 39
... decrease in morbidity and mortality ? That was the reason for the Agency focusing in general on this particular issue . In the case of Lopid , there seemed to be , as I have looked at the record , a very tight coordination between the ...
... decrease in morbidity and mortality ? That was the reason for the Agency focusing in general on this particular issue . In the case of Lopid , there seemed to be , as I have looked at the record , a very tight coordination between the ...
Page 43
... decreased morbidi- ty or mortality from heart disease . As far as we have been able to determine , this is the only Phase IV study ever required by FDA to investigate an unapproved claim . It is also our understanding that it is the ...
... decreased morbidi- ty or mortality from heart disease . As far as we have been able to determine , this is the only Phase IV study ever required by FDA to investigate an unapproved claim . It is also our understanding that it is the ...
Page 50
... decreased morbidity or mortality from heart disease . As far as we have been able to determine , this is the only Phase IV study ever required by FDA to investigate an unapproved claim . It is also our understanding that it is the ...
... decreased morbidity or mortality from heart disease . As far as we have been able to determine , this is the only Phase IV study ever required by FDA to investigate an unapproved claim . It is also our understanding that it is the ...
Page 62
... decreases . Patent # 3,674,836 issued covering Lopid ( gemfibrozil ) ( the " Lopid Patent " ) . A series of Lopid clinical studies launched in the United States and overseas . Studies range from 16 to 48 weeks ( average 28 weeks ) ...
... decreases . Patent # 3,674,836 issued covering Lopid ( gemfibrozil ) ( the " Lopid Patent " ) . A series of Lopid clinical studies launched in the United States and overseas . Studies range from 16 to 48 weeks ( average 28 weeks ) ...
Page 74
... was ultimately approved in December 1981 , unless a " Phase IV " study ( i.e. , a study conducted after approval of an NDA ) was immediately begun to demonstrate that - 3 use of Lopid results in decreased morbidity or 74.
... was ultimately approved in December 1981 , unless a " Phase IV " study ( i.e. , a study conducted after approval of an NDA ) was immediately begun to demonstrate that - 3 use of Lopid results in decreased morbidity or 74.
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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
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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.
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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...