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	<title>Life-Science Panorama</title>
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	<link>http://axendia.com/blog</link>
	<description>A Journal for Industry Executives</description>
	<pubDate>Wed, 10 Mar 2010 13:40:54 +0000</pubDate>
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		<title>FDA Requests $400M to Transform Operational and Regulatory Processes</title>
		<link>http://axendia.com/blog/2010/03/10/fda-requests-400m-to-transform-operational-and-regulatory-processes/</link>
		<comments>http://axendia.com/blog/2010/03/10/fda-requests-400m-to-transform-operational-and-regulatory-processes/#comments</comments>
		<pubDate>Wed, 10 Mar 2010 13:40:54 +0000</pubDate>
		<dc:creator>Daniel R. Matlis</dc:creator>
		
		<category><![CDATA[Business]]></category>

		<guid isPermaLink="false">http://axendia.com/blog/?p=548</guid>
		<description><![CDATA[<style>.newl {display:none}</style><div class=newl></div>By Daniel R. Matlis
One of the last remaining perks of a transcontinental flight is the ability to put on a set of noise cancelling headsets, listen to your favorite tunes and read through a hefty 600 plus page volume. I chose the 604 page Fiscal Year 2011 Food and Drug Administration Justification of Estimates for [...]]]></description>
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		<item>
		<title>FDA Deploys Sophisticated PREDICT Computer System</title>
		<link>http://axendia.com/blog/2010/02/11/fda-deploys-sophisticated-predict-computer-system/</link>
		<comments>http://axendia.com/blog/2010/02/11/fda-deploys-sophisticated-predict-computer-system/#comments</comments>
		<pubDate>Thu, 11 Feb 2010 13:06:56 +0000</pubDate>
		<dc:creator>Daniel R. Matlis</dc:creator>
		
		<category><![CDATA[Business]]></category>

		<guid isPermaLink="false">http://axendia.com/blog/?p=537</guid>
		<description><![CDATA[By Daniel R. Matlis
Last week, FDA Commissioner Dr. Margaret Hamburg formally announced the deployment of PREDICT&#8211;the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting.
&#8220;PREDICT is an exciting innovation that harnesses advances in information science to enable us to do our job better and to improve our service to the nation&#8221; said Dr. Hamburg. &#8220;But it [...]]]></description>
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		<item>
		<title>FDA Requesting $4.03 Billion for Fiscal Year 2011</title>
		<link>http://axendia.com/blog/2010/02/03/fda-requesting-403-billion-for-fiscal-year-2011/</link>
		<comments>http://axendia.com/blog/2010/02/03/fda-requesting-403-billion-for-fiscal-year-2011/#comments</comments>
		<pubDate>Wed, 03 Feb 2010 14:14:59 +0000</pubDate>
		<dc:creator>Daniel R. Matlis</dc:creator>
		
		<category><![CDATA[Business]]></category>

		<category><![CDATA[Regulatory]]></category>

		<guid isPermaLink="false">http://axendia.com/blog/?p=516</guid>
		<description><![CDATA[By Daniel R. Matlis
The FDA is requesting $4.03 billion to promote and protect public health as part of the fiscal year 2011 budget. This represents a 23 percent increase over the agency&#8217;s current $3.28 billion budget and includes a $146 million increase in budget authority and $601 million in industry user fees.
According to FDA Commissioner [...]]]></description>
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		</item>
		<item>
		<title>Lowering the Cost of Healthcare from Inside Out</title>
		<link>http://axendia.com/blog/2010/01/27/lowering-the-cost-of-healthcare-from-inside-out/</link>
		<comments>http://axendia.com/blog/2010/01/27/lowering-the-cost-of-healthcare-from-inside-out/#comments</comments>
		<pubDate>Wed, 27 Jan 2010 17:15:34 +0000</pubDate>
		<dc:creator>Daniel R. Matlis</dc:creator>
		
		<category><![CDATA[Business]]></category>

		<category><![CDATA[Regulatory]]></category>

		<category><![CDATA[Technology]]></category>

		<guid isPermaLink="false">http://axendia.com/blog/?p=479</guid>
		<description><![CDATA[
Healthcare providers are under more pressure than ever to improve clinical outcomes and reduce costs, while ensuring compliance with a myriad of applicable regulations. The proliferation of Medical Technologies has created a new level of complexity and risks for Healthcare organizations.
To meet these sometime divergent objectives, Healthcare providers must find ways to effectively manage a [...]]]></description>
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		<title>Key Initiatives Driving FDA&#8217;s Shift to eMDR</title>
		<link>http://axendia.com/blog/2010/01/19/key-initiatives-driving-fdas-shift-to-emdr/</link>
		<comments>http://axendia.com/blog/2010/01/19/key-initiatives-driving-fdas-shift-to-emdr/#comments</comments>
		<pubDate>Tue, 19 Jan 2010 13:56:45 +0000</pubDate>
		<dc:creator>Daniel R. Matlis</dc:creator>
		
		<category><![CDATA[Business]]></category>

		<category><![CDATA[Regulatory]]></category>

		<category><![CDATA[Technology]]></category>

		<guid isPermaLink="false">http://axendia.com/blog/?p=494</guid>
		<description><![CDATA[
The FDA has initiated the process to amend its postmarket medical device reporting regulation (21 CFR Part 803) to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs) to the agency in an electronic format.
The Agency currently processed and analyses approximately [...]]]></description>
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		<title>What to Expect from FDA in 2010</title>
		<link>http://axendia.com/blog/2009/12/15/what-to-expect-from-fda-in-2010/</link>
		<comments>http://axendia.com/blog/2009/12/15/what-to-expect-from-fda-in-2010/#comments</comments>
		<pubDate>Tue, 15 Dec 2009 14:57:36 +0000</pubDate>
		<dc:creator>Daniel R. Matlis</dc:creator>
		
		<category><![CDATA[Business]]></category>

		<guid isPermaLink="false">http://axendia.com/blog/?p=468</guid>
		<description><![CDATA[By Daniel R. Matlis
Adapted from an article published in MedicalDeviceSummit.com
FDA, like any other organization is comprised of people driven by collective goals, a mission and vision. The Agency&#8217;s mission is &#8220;protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation&#8217;s food supply, cosmetics, [...]]]></description>
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		<item>
		<title>FDA Seeks Input on Redesign of Form 483</title>
		<link>http://axendia.com/blog/2009/12/07/fda-seeks-input-on-redesign-of-form-483/</link>
		<comments>http://axendia.com/blog/2009/12/07/fda-seeks-input-on-redesign-of-form-483/#comments</comments>
		<pubDate>Mon, 07 Dec 2009 13:05:58 +0000</pubDate>
		<dc:creator>Daniel R. Matlis</dc:creator>
		
		<category><![CDATA[Business]]></category>

		<category><![CDATA[Regulatory]]></category>

		<guid isPermaLink="false">http://axendia.com/blog/?p=460</guid>
		<description><![CDATA[By Daniel R. Matlis
As part of the FDA&#8217;s transparency initiative, the agency seeks input from its constituents on whether inspectional observations reports (form 483) should be re-designed to make inspection findings available to the public quickly.
Form FDA-483 lists observations made during the inspection of a firm. Responding to Freedom of Information Act requests for 483s, [...]]]></description>
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		</item>
		<item>
		<title>FDA Using Internet to Broadcast Hearing on Internet and Social Media for Promoting Medical Products</title>
		<link>http://axendia.com/blog/2009/11/13/fda-using-internet-to-broadcast-hearing-on-internet-and-social-media-for-promoting-medical-products/</link>
		<comments>http://axendia.com/blog/2009/11/13/fda-using-internet-to-broadcast-hearing-on-internet-and-social-media-for-promoting-medical-products/#comments</comments>
		<pubDate>Fri, 13 Nov 2009 18:51:14 +0000</pubDate>
		<dc:creator>Daniel R. Matlis</dc:creator>
		
		<category><![CDATA[Business]]></category>

		<guid isPermaLink="false">http://axendia.com/blog/?p=457</guid>
		<description><![CDATA[By Daniel R. Matlis
What came first, the chicken or the egg?
In the case of FDA&#8217;s hearing on the &#8220;Promotion of Medical Products Using the Internet and Social Media Tools&#8221;, definitely the chicken.  FDA is using Internet and Social Media Tools to &#8220;stream&#8221; the hearing on the &#8220;Promotion of Medical Products Using the Internet and Social [...]]]></description>
		<wfw:commentRss>http://axendia.com/blog/2009/11/13/fda-using-internet-to-broadcast-hearing-on-internet-and-social-media-for-promoting-medical-products/feed/</wfw:commentRss>
		</item>
		<item>
		<title>FDA Issues Reminder on Networked Medical Devices Cybersecurity</title>
		<link>http://axendia.com/blog/2009/11/04/fda-medical-devices-cybersecurity-remainder/</link>
		<comments>http://axendia.com/blog/2009/11/04/fda-medical-devices-cybersecurity-remainder/#comments</comments>
		<pubDate>Wed, 04 Nov 2009 20:14:44 +0000</pubDate>
		<dc:creator>Daniel R. Matlis</dc:creator>
		
		<category><![CDATA[Business]]></category>

		<guid isPermaLink="false">http://axendia.com/blog/?p=452</guid>
		<description><![CDATA[By Daniel R. Matlis
The issue of networked medical devices has come from and center with two recent Life-Science Panorama articles focused on the topic.
&#8220;Hospitals &#38; Medical Device Manufacturers Address Interoperability with New Standard&#8220;  by Oliver P. Christ, CEO Healthcare of PROSYSTEM AG discussed the emergence of standards and regulations around communications involving medical devices.
&#8220;Is Medical [...]]]></description>
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		</item>
		<item>
		<title>CAMSTAR Poised to Support Medical Product Manufacturing in APAC</title>
		<link>http://axendia.com/blog/2009/10/30/camstar-poised-to-support-medical-product-manufacturing-in-apac/</link>
		<comments>http://axendia.com/blog/2009/10/30/camstar-poised-to-support-medical-product-manufacturing-in-apac/#comments</comments>
		<pubDate>Fri, 30 Oct 2009 16:28:00 +0000</pubDate>
		<dc:creator>Daniel R. Matlis</dc:creator>
		
		<category><![CDATA[Business]]></category>

		<guid isPermaLink="false">http://axendia.com/blog/?p=443</guid>
		<description><![CDATA[By Daniel R. Matlis
Last week, Karim Lokas, Vice President of Product Strategy for Camstar Systems, briefed me on the company&#8217;s acquisition of Technology Resources Group (TRG). A recognized leader in the Asia Pacific (APAC) region, TRG has expertise in manufacturing execution, equipment automation, manufacturing applications development, and program management for enterprise solution deployments. The acquisition [...]]]></description>
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