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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... ( 1986 ) . 254 2. Levy , Robert I. ( ed . ) , " Lipid Regulation : A New Era in the Prevention of Coronary Heart Disease " , American Heart Journal ( 1984 ) . 320 LOPID PATENT TERM RESTORATION AND FAIRNESS ACT OF 1987 THURSDAY IV.
... ( 1986 ) . 254 2. Levy , Robert I. ( ed . ) , " Lipid Regulation : A New Era in the Prevention of Coronary Heart Disease " , American Heart Journal ( 1984 ) . 320 LOPID PATENT TERM RESTORATION AND FAIRNESS ACT OF 1987 THURSDAY IV.
Page 43
... Journal of Medicine . In terms of chronology , Mr. Chairman , the requirement for Warner - Lambert to conduct the Phase IV study on Lopid was man- dated in 1981. At that time , a vastly different FDA regulatory proc- ess existed . Then ...
... Journal of Medicine . In terms of chronology , Mr. Chairman , the requirement for Warner - Lambert to conduct the Phase IV study on Lopid was man- dated in 1981. At that time , a vastly different FDA regulatory proc- ess existed . Then ...
Page 52
... Journal of Medicine . While the study's final findings are not publicly available , the Helsinki Heart Council has advised us that the initial data trends are highly encouraging . We believe the Helsinki Study will take its place ...
... Journal of Medicine . While the study's final findings are not publicly available , the Helsinki Heart Council has advised us that the initial data trends are highly encouraging . We believe the Helsinki Study will take its place ...
Page 59
... Journal of Medicine . While Warner - Lambert does not have direct information concerning the date of publication , normal procedure would seem to indicate a publication date in mid to late October or sometime in November . II . LOPID ...
... Journal of Medicine . While Warner - Lambert does not have direct information concerning the date of publication , normal procedure would seem to indicate a publication date in mid to late October or sometime in November . II . LOPID ...
Page 63
... journal . 1989 Lopid Patent expires on July 4 , 1989 . 1988 1987- It is projected that Warner - Lambert will file a Supplemental NDA for the expanded claim , which promises to be justified by the Helsinki Heart Study results , in late ...
... journal . 1989 Lopid Patent expires on July 4 , 1989 . 1988 1987- It is projected that Warner - Lambert will file a Supplemental NDA for the expanded claim , which promises to be justified by the Helsinki Heart Study results , in late ...
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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...