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	<title>Strategic Regulatory Consulting: Medical Writing, Toxicology and Regulatory Consulting</title>
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		<title>UDI Compliance Check Will Not Be Part of Premarket Review</title>
		<link>http://srcteam.com/udi-compliance-check-will-not-be-part-of-premarket-review/</link>
		<comments>http://srcteam.com/udi-compliance-check-will-not-be-part-of-premarket-review/#comments</comments>
		<pubDate>Fri, 18 Mar 2011 19:56:46 +0000</pubDate>
		<dc:creator>carinemily</dc:creator>
				<category><![CDATA[Devices]]></category>
		<category><![CDATA[Drugs]]></category>
		<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://srcteam.com/src/?p=637</guid>
		<description><![CDATA[As the FDA prepares to release its proposed rule for a unique device identifier (UDI) database, devicemakers are off the hook for UDI label scrutiny during premarket review. “It could be that our reviewers want to see some information, but at this point we don’t have any specific plans for UDI to be part of <a href='http://srcteam.com/udi-compliance-check-will-not-be-part-of-premarket-review/'>[...]</a>]]></description>
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		<title>Gender Disparity in Trials to Prompt New Guidance</title>
		<link>http://srcteam.com/gender-disparity-in-trials-to-prompt-new-guidance/</link>
		<comments>http://srcteam.com/gender-disparity-in-trials-to-prompt-new-guidance/#comments</comments>
		<pubDate>Fri, 18 Mar 2011 14:31:05 +0000</pubDate>
		<dc:creator>carinemily</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://srcteam.com/src/?p=613</guid>
		<description><![CDATA[The FDA plans to issue a guidance this year to help sponsors address gender disparity in clinical trial data submitted to the agency. Over the last several years, the Center for Devices and Radiological Health (CDRH) has hosted a series of public workshops to gain input on achieving appropriate gender representation and conducting analysis for <a href='http://srcteam.com/gender-disparity-in-trials-to-prompt-new-guidance/'>[...]</a>]]></description>
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		<title>Medical Technology Industry Lobbies for Tax Credit</title>
		<link>http://srcteam.com/medical-technology-industry-lobbies-for-tax-credit/</link>
		<comments>http://srcteam.com/medical-technology-industry-lobbies-for-tax-credit/#comments</comments>
		<pubDate>Fri, 18 Mar 2011 13:00:15 +0000</pubDate>
		<dc:creator>carinemily</dc:creator>
				<category><![CDATA[News]]></category>

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		<description><![CDATA[The big guns in medical technology are lining up to support a bill recently introduced in Congress that would make a research-and-development tax credit a permanent part of the federal tax code.]]></description>
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		<title>FDA News Release</title>
		<link>http://srcteam.com/fda-news-release/</link>
		<comments>http://srcteam.com/fda-news-release/#comments</comments>
		<pubDate>Tue, 08 Mar 2011 21:16:37 +0000</pubDate>
		<dc:creator>carinemily</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://srcteam.com/src/?p=202</guid>
		<description><![CDATA[FDA to improve most common review path for medical devices Goals are to foster device innovation, protect patient safety The U.S. Food and Drug Administration today unveiled a plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices. Key actions include: Streamlining the “de <a href='http://srcteam.com/fda-news-release/'>[...]</a>]]></description>
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