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Independent Testing and the FDA
(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 in China
(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…
Food Quality and the Global Food Supply Chain
(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…
Flaws in New Consumer-Driven Health Plans
(EBRI: Wasington, D.C.) -- A relatively new health plan model that advocates hope will control rising health spending could fail if key consumer education initiatives prove ineffective, according to a study recently published by the nonpartisan Employee Benefit Research Institute.The study,…
NCQA Program to Evaluate Patient-Centered Medical Homes
(NCQA: Washington, DC) -- The National Committee for Quality Assurance launched a new version of its Physician Practice Connections (PPC) program designed to assess how medical practices are functioning as patient-centered medical homes. The new Physician Practice Connections—Patient-Centered…
Pharmacy Call Ahead Program Saves Time and Money
(ScripNet: Las Vegas) - To ease the availability of prescription medications to injured workers, ScripNet, a pharmacy benefits manager, is saving time and money with its innovative Call Ahead Program.“We launched the Call Ahead Program over a year ago to make it easier on the injured worker, to…
Efficiency Improvement Through Adoption of New Health Care Data-Mining Technology
(Siemens Healthcare: Orlando, Florida) -- Siemens health care data-mining tool, Soarian Quality Measures, replaces time-consuming manual chart reviews with highly accurate and automated chart abstraction of quality measures, as defined by the Centers for Medicare and Medicaid Services and The…
Nationwide Recall of Prefilled Heparin and Normal Saline Flushes
(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…
Chinese State FDA Completes Technical Review of Oral HIV Test Application
(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…
Computer Systems Validation in FDA-Related Industries Conference
(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…
FDA Approves Improvement to Unigene’s Manufacturing Process
(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…
Learning from Medical Mistakes
(Agency for Healthcare Research and Quality: Rockville, MD) -- According to a new study funded by the Department of Health and Human Services’ Agency for Healthcare Research and Quality, most doctors’ think that current systems to report and share information about errors are inadequate.…
Lumetra Program Improves Diabetes Care Among Latinos
(Lumetra: San Francisco) -- Investing in culturally-appropriate, community-based interventions substantially improved rates of A1C testing among Latinos with diabetes, according to a new study published in the February American Journal of Public Health. Proper diabetes care management is essential…
Health Reform in Kazakhstan
(World Bank: Astana, Kazakhstan) -- The World Bank’s board of executive directors recently approved a US$117.7 million loan for the Kazakhstan Health Sector Technology Transfer and Institutional Reform Project. The project will introduce international standards to the Ministry of Health and…
“Spanning the Quality Chasm” Conference
(AQHA: Washington, D.C.) -- The annual American Quality Health Association meeting will be held in San Francisco, California, Feb. 26–28, 2008. National health care leaders from quality improvement organizations, the Centers for Medicare and Medicaid Services, and other public and private…
Compounded Hormone Therapy Drug-makers Warned
(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…
Audio Conference on FDA’s Revised Standards for Water CGMPs
(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 Issues Documents on the Safety of Food from Animal Clones
(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
(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…
WCBF Seventh Annual Six Sigma and Process Improvement in Healthcare Summit
(WCBF: Las Vegas) -- WCBF will host the Seventh Annual Six Sigma and Process Improvement in Healthcare Summit in Las Vegas, April 1–4, 2008. The focus will be on lean, Six Sigma, and other process improvement methodologies within the health care system.  The summit will feature nine presummit…
Senators Foster E-Prescriptions
(U.S. Senate: Washington, D.C.) -- The cost of poor quality in health care accounts for from 30 to 60 cents of every health care dollar. Senators John Kerry (D-Mass.) and John Ensign (R-Nev.) along with a bipartisan group of legislators have introduced a bill that would expedite the adoption of…
USGBC and GGHC Working to Green Health Care
(USGBC: Washington, D.C.) -- The U.S. Green Building Council and the Green Guide for Health Care have agreed to help green the health care industry by fostering best practices and ensuring that the health care industry has the tools and resources to build green. Green hospital buildings are…
2007 Malcolm Baldrige National Quality Award Winner Mercy Health System
(Mercy Health System: Janesville, Wisconsin) -- Mercy Health System, a recipient of the 2007 Malcolm Baldrige National Quality Award, is recognized for organizational excellence across its entire vertically integrated organization spanning three hospitals, 285 employed physicians and their…
Call for National Voluntary Consensus Standards for Health Care IT
(NQF: Washington, D.C.) -- National Quality Forum is formally soliciting candidate measures for review and evaluation for potential inclusion in its set of NQF-endorsed voluntary consensus standards for health care information technology (HIT). Any organization or individual may submit…
CIGNA HealthCare Teams with Thomson’s MedStat Data Services
(CIGNA HealthCare: Bloomfield, Connecticut) -- In an effort to manage the high-volume data used in its health advocacy programs, CIGNA HealthCare is teaming up with Thomson Healthcare’s MedStat data services. By employing greater data management, the goal for CIGNA HealthCare is to engage…

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