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 31
Page 4
... application to expand the permitted indications and usage in the la- beling of the new drug based upon such phase IV clini- cal study has been submitted to the Federal Food and Drug Administration , and 1 2 3 4 5 6 7 3 " (
... application to expand the permitted indications and usage in the la- beling of the new drug based upon such phase IV clini- cal study has been submitted to the Federal Food and Drug Administration , and 1 2 3 4 5 6 7 3 " (
Page 19
... 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 case of new drugs , we are responsible for reviewing whether an applicant for ...
... 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 case of new drugs , we are responsible for reviewing whether an applicant for ...
Page 24
... 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 whose primary mission , in the case of new drugs , is to review whether an ...
... 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 whose primary mission , in the case of new drugs , is to review whether an ...
Page 25
... indication FDA allowed in the physician's package insert labeling was for lowering serum triglycerides rather than for lowering serum cholesterol , although a very restricted indication for lowering serum cholesterol was permitted . It ...
... indication FDA allowed in the physician's package insert labeling was for lowering serum triglycerides rather than for lowering serum cholesterol , although a very restricted indication for lowering serum cholesterol was permitted . It ...
Page 32
... indications or for indications contained in the same or other patents . So there were limitations built 32.
... indications or for indications contained in the same or other patents . So there were limitations built 32.
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...