Category: Regulations

  • Lean Management Helps Improve Surgery Efficiency, Morale

    Researchers and clinicians from University of Michigan medical school and health system in Ann Arbor adapted lean management concepts from industry to one hospital operating room and found improved efficiency and morale, with implications for increasing hospital capacity and revenues. The results of the study appear online in the Journal of the American College of…

  • New Standards Released for Drug Impurity Limits, Methods

    U.S. Pharmacopeial Convention (USP) in Rockville, Maryland has published two new standards governing elemental impurities in medications. USP says conformance to the standards will be required starting 1 May 2014. Elemental impurities include catalysts and environmental contaminants such as lead or mercury that may be present in drugs. According to USP, elemental impurities can occur…

  • FDA Approves Assay for Rare Cell Disorders

    The U.S. Food and Drug Administration approved a new test to help physicians diagnose a group of rare cell disorders. The test, or assay, was developed by Lawrence Schwartz (pictured right), a medical school professor at Virginia Commonwealth University in Richmond and a researcher in the field of mast cells. Mast cells are found in…

  • Statins Found to Reduce Cancers After Heart Transplants

    A study by physicians and medical researchers at University Hospital Zurich in Switzerland indicates heart transplant patients taking statins — drugs used to lower cholesterol — reduced their risk of getting cancer, and were associated with overall survival independent of their cholesterol levels. The findings were reported yesterday at a meeting of the European Society…

  • Genetic Tests Not Triggering More Health Care Use

    Researchers at Group Health Research Institute in Seattle, National Institutes of Health, Henry Ford Hospital in Detroit, and Abt Associates in Bethesda, Maryland found patients who receive genetic tests for susceptibility to disease were no more likely to use medical services after receiving the results than before the tests. The study results appear online today…

  • Study: FDA Approves Drugs Faster Than in Europe, Canada

    Researchers at the Yale University medical school have found that since 2001, the U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe. The findings of medical student Nicholas Downing and colleagues appear online in the New England Journal of Medicine. Downing’s team, under the…

  • Two Paralyzed People Use Brain-Controlled Robotic Arms

    Two stroke victims with tetraplegia — total loss of the use of limbs and torso — were able to control robotic arms with brain activity to reach, grasp, and use physical objects. The results of this study from the BrainGate project are reported today online in the journal Nature (paid subscription required). The BrainGate project…

  • U.S. Patent Awarded for Synthetic Hepatitis C Biocatalysts

    The U.S. Patent and Trademark Office awarded yesterday a patent covering biocatalysts and biocatalytic processes used to make intermediate products in the synthesis of hepatitis C drugs. Patent number 8,178,333 was awarded to 13 inventors and assigned to Codexis Inc. in Redwood City, California. Codexis is a biotechnology company that develops and markets engineered enzymes…

  • Imaging Technique Highlights Cardiac Arrest Candidates

    Medical researchers from University at Buffalo have adapted Positron Emission Tomography (PET) imaging to identify patients at the highest risk for sudden cardiac arrest. Results of the clinical trial testing the technique are scheduled for presentation today at a meeting of the Heart Rhythm Society. The university says the Prediction of Arrhythmic Events with Positron…

  • Air Force Funds Moving Target Network Study to Stop Hackers

    Computer scientists at Kansas State University in Manhattan are investigating ways of improving the security of computer networks, by constantly changing their configurations. The project is funded by a five-year grant from the Air Force Office of Scientific Research valued at more than $1 million. Computing and information schience professors Scott DeLoach, and Xinming “Simon”…