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(HHS: Washington, D.C.) -- The U. S. Department of Health and Human Services stated that efforts are underway between the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services (CMS) to improve patient safety and the quality of medical care.“This initiative will…
CRO Completes Multinational Training Program for Principal Investigators from China, Duke University
Lisa Mazurka and the clinical investigators involved in the training is available
(Clinical Research Consulting Inc.: Boston, Massachusetts) -- Clinical Research Consulting Inc., a contract research organization (CRO) specializing in clinical monitoring, project management, education and…
(Pharmaceutical Technology Magazine: Iselin, New Jersey) – QPEC’s Annual Quality and Process Excellence Conference will be held from July 21-23 at the Westin Arlington Gateway in Arlington, Virginia. The conference is sponsored by Pharmaceutical Technology Magazine. This case study-driven…
(Research and Markets: Dublin, Ireland) – A Frost & Sullivan research service titled “Automation and Control Solutions in the European Pharmaceutical Market” provides an analysis of the various factors driving and restraining the market, revenue forecasts, geographic trends and…
(Washington, D.C.) — Republican senator Chuck Grassley of Iowa has asked for an independent assessment of how the Food and Drug Administration (FDA) follows up on the effects of medicines that it approves based on narrowly defined benefits.“The way things have turned out with drugs like…
(Zimmer Holdings Inc.: Warsaw, Indiana) -- Zimmer Holdings Inc. has recently taken a number of actions to improve quality systems at its Dover, Ohio, facility, which manufactures Zimmer Orthopedic Surgical Products (OSP). Zimmer recently conducted a review of quality systems at the Dover, Ohio…
(UCSF: San Francisco) -- The approval process for medical devices doesn’t involve the same rigorous review used for pharmaceuticals, and to improve health outcomes this needs to change, say researchers from the University of California, San Francisco.In the January 2008 issue of the Journal of…
(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…
(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…
(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…
(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…
(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…
(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…
(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…
(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…
(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…
