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		<title>RedLine: February 10, 2010</title>
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FDA Opens Dialogue on Device Challenges



The federal government closed on February 9, 2010, due to major snow accumulations, but the Food and Drug Administration (FDA) persevered with its scheduled meeting to discuss how new science should be incorporated into regulatory decision-making. 
Jeff Shuren, MD, JD, the new Director of the Center for Devices and Radiological Health [...]]]></description>
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		<title>RedLine: January 14, 2010</title>
		<link>http://www.auburnstrat.com/2010/01/redline-january-14-2010/</link>
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		<pubDate>Thu, 14 Jan 2010 05:25:08 +0000</pubDate>
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January 14, 2010
 








RedLine  
Auburn Health Strategies newsletter







 


 






Next Steps in Health Reform



In an effort to reconcile the differences between the House-passed Affordable Health Care for America Act (HR 3962) and the Senate-passed Patient Protection and Affordable Care Act (HR 3590), it appears that Congress will bypass a formal conference committee and rely instead on a procedure commonly [...]]]></description>
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		<title>RedLine: September 10, 2009</title>
		<link>http://www.auburnstrat.com/2009/09/redline-september-10-2009/</link>
		<comments>http://www.auburnstrat.com/2009/09/redline-september-10-2009/#comments</comments>
		<pubDate>Fri, 11 Sep 2009 00:06:24 +0000</pubDate>
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September 10, 2009
 








RedLine  
Auburn Health Strategies newsletter







 


 






Assuring Lab Quality During Public Health Emergencies


How can laboratories assure quality during public health emergencies?  It was a question pondered during the September 2009 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC).  As more Americans experience fevers, sore throats, and body aches, many laboratories have been pressed to test [...]]]></description>
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		<title>RedLine: July 9, 2009</title>
		<link>http://www.auburnstrat.com/2009/07/redline-july-9-2009/</link>
		<comments>http://www.auburnstrat.com/2009/07/redline-july-9-2009/#comments</comments>
		<pubDate>Thu, 09 Jul 2009 16:46:17 +0000</pubDate>
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July 9, 2009
 








RedLine  
Auburn Health Strategies newsletter







 


 






Supreme Court Ruling Impacts Forensic Science


The U.S. Supreme Court issued an opinion on June 25, 2009, that may impact the practice of forensic science.  In Melendez-Diaz v. Massachusetts, the Court held that sworn certificates from a state laboratory analyst may not be submitted as prima facie evidence since the [...]]]></description>
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		<title>Redline:  January 14, 2008</title>
		<link>http://www.auburnstrat.com/2009/03/redline-january-14-2008/</link>
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		<pubDate>Thu, 12 Mar 2009 18:45:24 +0000</pubDate>
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		<description><![CDATA[January 14, 2008
RedLine 
&#160;
Trend:&#160; Rapid Testing Advances 
The Food and Drug  Administration cleared for marketing the xTag Respiratory Viral Panel  manufactured by Luminex Molecular Diagnostics, Inc.&#160; The decision, issued on  January 3, 2008, marks the first time FDA cleared an assay that detects and  identifies 12 viruses and viral subtypes.&#160; Together, [...]]]></description>
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		<title>Redline:  March 4, 2008</title>
		<link>http://www.auburnstrat.com/2009/03/redline-march-4-2008/</link>
		<comments>http://www.auburnstrat.com/2009/03/redline-march-4-2008/#comments</comments>
		<pubDate>Thu, 12 Mar 2009 18:44:32 +0000</pubDate>
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March 4, 2008
RedLine 
&#160;
Steps to Becoming a Patient Safety Organization
Creating an infrastructure that  allows for the capture of information on medical errors, yet protects the  confidentiality of that data, the patient and provider, is the subject of a new  proposed regulation on Patient Safety and Quality Improvement.&#160;&#160; The proposed  rule, issued [...]]]></description>
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		<title>Redline:  May 2, 2008</title>
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		<pubDate>Thu, 12 Mar 2009 18:43:14 +0000</pubDate>
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May 2, 2008
RedLine 
&#160;
Genetic Tests Similar to Other Complex Tests Says SACGHS
&#8220;Concerns associated with  genetic testing generally do not differ from other complex laboratory tests,&#8221;  stated the leaders of the Secretary&#8217;s Advisory Committee on Genetics, Health and  Society (SACGHS) in a letter to the Secretary of Health and Human Services,  Michael [...]]]></description>
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		<title>Redline:  May 23, 2008</title>
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		<comments>http://www.auburnstrat.com/2009/03/redline-may-23-2008/#comments</comments>
		<pubDate>Thu, 12 Mar 2009 18:41:45 +0000</pubDate>
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&#160;






2007 Status Report on Laboratory Medicine


&#160; 
&#160;
                        The Centers for Disease Control and Prevention commissioned a report on the status of laboratory medicine.&#160; Recently made available, the 2007 draft report is open [...]]]></description>
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