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(FDA: Rockville, Maryland) -- In an effort to facilitate stronger cooperative relationships with its counterpart agencies around the world, the United States Food and Drug Administration (FDA) plans to establish eight full-time, permanent positions at U.S. diplomatic posts in the People’s…
(Journal of Supply Chain Management: Clemson, North Carolina) -- A new study from the Journal of Supply Chain Management illustrates the real potential for contamination of globally sourced foods and proposes a conceptual framework of supply chain quality management.Led by Aleda V. Roth of…
(Modulo: New York) -- In an effort to streamline its risk assessment and compliance processes, New York University Medical Center has selected the Modulo Risk Manager, an automated information tool.As one of the nation’s largest research and academic medical centers, NYUMC is subject to…
(Calypte Biomedical Corp: Portland, Oregon) -- Calypte Biomedical Corp., a developer, manufacturer and marketer of HIV diagnostic tests, recently announced that the Chinese State Food and Drug Administration (SFDA)—the equivalent of the U.S. FDA—has notified Calypte’s Chinese manufacturing…
(Advanstar: Iselin, New Jersey) -- The Institute of Validation Technology, a division of Advanstar Communications, will host the “Computer Systems Validation in FDA-Regulated Industries” conference in Baltimore, Maryland, April 29–May 2. The conference will provide updated interactive…
(Unigene Laboratories Inc: Fairfield, New Jersey) -- The U.S. Food and Drug Administration has approved a modification for a key enzyme, the first of two proposed improvements for Unigene Laboratories Inc.’s patented manufacturing process for calcitonin, the active ingredient in Fortical, a…
(AM2 PAT Inc.: Angier, North Carolina) -- A nationwide recall of Heparin and Saline prefilled flushes manufactured by AM2 PAT was issued by AM2 PAT. These products are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun. These products are sold in 3-ml and 5-ml sizes for Heparin…
(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration has sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of so-called bio-identical hormone replacement therapy (BHRT) products are unsupported by medical evidence, and…
(FDANews: Falls Church, Virginia) --The Food and Drug Administration recently issued proposed changes to the drug-manufacturers’ clinical good manufacturing practices (CGMPs) (21 CFR 210/211). The revised standards would affect three major areas: water quality, verification by a second…
(FDA: Rockville, Maryland) -- After years of study and analysis, the Food and Drug Administration has concluded that meat and milk from clones of cattle, swine, and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from…
(Food Safety and Security Summit: Washington, D.C.) From farm gate to dinner plate, the 10th annual Food Safety and Security Summit, held March 17–19, 2008, at the Washington, D.C., Convention Center, is the largest and most established food safety and security expo and conference in North…
(The Center for Business Intelligence: Woburn, Massachusetts) – CBI will host the conference with the theme, “Implement a Strategy for Continuous Quality Systems Improvement in Accordance with ICH Q10 Guidelines,” January 24–25, 2008, in Philadelphia.ICH Q10 describes one comprehensive approach…
(AHRQ: Rockville, Maryland) -- An array of toolkits designed to help doctors, nurses, hospital managers, patients, and others reduce medical errors was recently released by the U.S. Health and Human Services’ Agency for Healthcare Research and Quality.The 17 toolkits, developed by AHRQ-funded…
(CBI: Woburn, Massachusetts) -- The Center for Business Intelligence will hold the Quality Assurance/Quality Control (QA/QC) Process Improvement Summit for Bio/Pharmaceutical & Medical Devices on Jan. 24-25, 2008 in Philadelphia. This conference focuses on industry-specific tools and…
(Sciemetric Instruments: Ottawa, Canada) -- Sciemetric Instruments has announced the general availability of SigPOD Medical, a system to verify parts and processes in the manufacturing of medical devices.Regulatory initiatives such as the Food and Drug Administration’s Process Analytical…
In October, Medtronic Inc., makers of a wide range of medical devices, issued a voluntary suspension of its Sprint Fidelis defibrillation leads due to an increasing rate of lead fractures.Rob Clark, Medtronic senior director of public relations, says the decision was based on both a statistical…
(Cardinal Health: Dublin, Ohio) -- Cardinal Health, a global provider of products and services that improve the safety and productivity of health care, recently announced a new service to help hospitals combat methicillin-resistant staphylococcus aureus (MRSA) infections that are responsible…
(Duke University Medical Center: Durham, North Carolina) -- Using acupuncture before and during surgery significantly reduces the level of pain and the amount of potent painkillers needed by patients after the surgery is over, according to Duke University Medical Center anesthesiologists who…
(Pfizer: New York, and Sermo: Cambridge, Massachusetts) -- Pfizer Inc. and Sermo, the nation’s largest online physician community, recently announced a strategic collaboration designed to redefine the way physicians in the United States and the health care industry work together to improve…
(Juran: Southbury, Connecticut) -- A growing trend among hospitals is the use of lean techniques to improve patient safety measures, in turn improving the overall quality of care. Juran Healthcare’s patient safety model incorporates the Juran Trilogy (safety planning, safety compliance, and…
(ANSI: Washington, D.C.) -- Filling a prescription is faster and more convenient than ever thanks to a new standard from ANSI-accredited standards developer the National Council for Prescription Drug Programs Inc. Providing general guidelines for developers of pharmacy or physician management…
(NCQA: Washington) -- The quality of care for more than 80 million people in the United States enrolled in 767 accountable health plans improved in 2006, according to a new report by the National Committee for Quality Assurance.The State of Health Care Quality 2007 reports that commercial health…
(Johns Hopkins Medicine: Baltimore, Maryland) -- Mandatory classes that aim to improve the quality of medical care seem to successfully teach doctors new concepts but don’t necessarily improve patient outcomes, suggests a thorough review of articles that examine quality improvement (QI)…
(ASQ: Milwaukee, Winsconsin) -- As Food and Drug Administration regulations and quality system requirements tighten, manufacturers can’t afford the ramifications of unidentified risks in production. To help educate producers, the American Society for Quality is offering a one-day virtual course…
(National Institutes of Health: Bethesda, Maryland) -- National Institutes of Health director, Elias A. Zerhouni, M.D., has announced the expansion of a national consortium that is transforming how clinical and translational research is conducted at academic health centers across the country.…