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1Unique Device Identification: Still Coming 1 Citation In March, the Advancing Patient Safety Coalition, representing 24 healthcare companies, reiterated to FDA its interest in the implementation of a mandatory medical device unique device identification (UDI) system. A UDI system was mandated in the FDA Amendments Act of 2007, but the center has appeared too overwhelmed to do much about it. In a letter to Commissioner Andrew von Eschenbach, the coalition said an identifier ?is a crucial factor in improving patient safety, reducing medical errors,, technorati.com
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Sinupret for Kids Bionorica's Natural Remedy 1 Citation Sinupret for Kids, developed by Bionorica, is a safe, natural remedy that supports healthy sinus, respiratory and immune function. It is one of the world's leading herbal remedies for upper respiratory health for children age 2 and up. Here is the "Love You More" commercial now airing on TV. Watch and learn more on http://sinupretforkids.com. Duration : 0:0:33 (more?), technorati.com
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1 Citation ¿La FDA cediendo a las presiones políticas y económicas de poderosos intereses? Ok that´s odd. A inicios de los 90´s vetó la importación de este potente endulzante no calórico, orgánico y natural por un simple e irrisorio estudio fantasma dando luz verde a otros compuestos como el aspartame --con toda la evidencia que se tenía en ese momento y que se sigue actualmente acumulando sobre sus efectos nocivos en la salud-- de forma incomprensible. O sea, se comprende desde la perspectiva verde prens, technorati.com
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FDA: Innohep (tinzaparin sodium injection) 1 Citation Innohep (tinzaparin sodium injection)FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study?s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.In July 2, technorati.com
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FDA Survey Reveals Lead in Many Vitamins 1 Citation News regarding the presence of lead in certain paints and, frighteningly, in a number of recalled toys and imported candies has been widespread, and is something many of us are aware of. However, the U.S. Food and Drug Administration has revealed another surprising source of lead exposure?women?s and children?s vitamins. In survey data released by the , technorati.com
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Venom-Derived Drug Trial Gets FDA OK 1 Citation Life Sciences, FDA, clinical trials Ryan McBride wrote: Transmolecular, a Cambridge, MA-based biotech firm, reports that the FDA has agreed to consider a filing for approval of its lead anti-cancer drug (TM601) if the molecule meets goals of a late-stage clinical trial, under the agency?s so-called Special Protocol Assessment process. The trial will test the molecule?derived from yellow scorpion venom?as a treatment for patients with lethal brain tumors called glioblastoma multiforme. Comments, technorati.com
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FDA reports its efforts to make food supplies safe in the US 1 Citation Recently, different circles have been criticizing the U.S. Food and Drug Administration regarding its poor performance to make food supply in the U.S. safe. FDA responds to this criticism in a report that details its efforts to make food supplies safe and protect consumers. Dr. David Acheson, who is assistant commissioner for food protection at the agency, says in this connection: ?The agency?s proposal to develop better relationships with different local health departments and state regarding, technorati.com
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US: Poison Prevention Packaging Act and Bath and Body Makers 1 Citation The FDA isn?t the only governing body that affects the businesses of perfumers and other cosmetic enhancements in the US. Nope, we get bunches more: the EPA, the Department of Agriculture, the IRS?and the US Consumer Product Safety Commission.1 This latest act covers childproofing laws: if your products contain certain chemicals, your packages are required to Click it up!, technorati.com
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24/7 Wall St.: Alpha Natural Resources, Looking Beta, Off The 1 Citation 24/7 Wall St.: Alpha Natural Resources, Looking Beta, Off The Alpha Natural Resources (NYSE:ANR) has sold its majority interest in lime manufacturing plant in Kentucky and 17.6 million tons of coal that still needs to be mined. The after-tax gain from the sale of both properties is expected to be According to a report issued to Congress by the Natural Resources Defense Council, 60 to 70 percent of bottled water brands are packaged and sold within the same state, exempting them from FDA regul, technorati.com
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Pharma Must "Continue to Take Chances" In Policy World: Merck VP's Parting Advice 1 Citation We recently had the chance to talk at length with Merck VP-global public policy Ian Spatz (right, not actual size) about the challenges and opportunities facing industry amid the changes in Washington.We've always found him to be a very thoughtful analyst of the policy climate, and a very forward thinking advocate for ways to improve that environment. (That's why, among other things, he is a regular on the program at FDC-Windhover's FDA-CMS Summit, and will be speaking there on Friday.)Come Janu, technorati.com
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