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	<title>Regenerative Medicine Guru &#187; OCTGT</title>
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	<description>The Knowledge Portal to Help Regenerative Medicine Products Reach the Clinic Sooner</description>
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		<title>Will Fibrocell Sciences be the 1st Regenerative Medicine Product Approved by the FDA in over 12 Years?</title>
		<link>http://regenmedguru.com/will-fibrocell-sciences-be-the-1st-regenerative-medicine-product-approved-by-the-fda-in-over-12-years</link>
		<comments>http://regenmedguru.com/will-fibrocell-sciences-be-the-1st-regenerative-medicine-product-approved-by-the-fda-in-over-12-years#comments</comments>
		<pubDate>Mon, 02 Nov 2009 03:24:35 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[OCTGT]]></category>
		<category><![CDATA[regenerative medicine]]></category>

		<guid isPermaLink="false">http://regenmedguru.com/?p=127</guid>
		<description><![CDATA[I had a chance to attend part of the October 09, 2009 FDA Cellular, Tissue and Gene Therapies Advisory Committee meeting to discuss the biologic license application (BLA) for Fibrocell Science&#8217;s autologous fibroblast product intended to treat nasolabial fold wrinkles. Don&#8217;t be surprised if you have never heard of Fibrocell Science, Inc. Prior to filling [...]


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		<slash:comments>5</slash:comments>
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		<title>IXA Statement on Xenotransplants for Type 1 Diabetes</title>
		<link>http://regenmedguru.com/ixa-statement-on-xenotransplants-for-type-1-diabetes</link>
		<comments>http://regenmedguru.com/ixa-statement-on-xenotransplants-for-type-1-diabetes#comments</comments>
		<pubDate>Fri, 07 Aug 2009 15:48:15 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[4Rs]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[OCTGT]]></category>
		<category><![CDATA[regenerative medicine]]></category>
		<category><![CDATA[xenotransplantation]]></category>

		<guid isPermaLink="false">http://regenmedguru.com/?p=88</guid>
		<description><![CDATA[For those of you following developments in the field of xenotransplantation, the International Xenotransplantation Association (IXA) has recently developed a proposed Consensus Statement on Conditions for Undertaking Clinical Trials of Porcine Islet Products in Type 1 Diabetes. In my quick read of the statement it appears to be a comprehensive, well thought out document that [...]


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		<slash:comments>0</slash:comments>
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		<title>Cautionary Tale: Tumors Caused by Neural Stem Cells</title>
		<link>http://regenmedguru.com/77</link>
		<comments>http://regenmedguru.com/77#comments</comments>
		<pubDate>Thu, 19 Feb 2009 15:49:35 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[OCTGT]]></category>
		<category><![CDATA[regenerative medicine]]></category>
		<category><![CDATA[Stem cell]]></category>
		<category><![CDATA[Stem cell treatments]]></category>
		<category><![CDATA[US Food and Drug Administration]]></category>

		<guid isPermaLink="false">http://regenmedguru.com/?p=77</guid>
		<description><![CDATA[I usually avoid commenting on current events occurring in the field of regenerative medicine, primarily because I can&#8217;t keep up!  In this case,  I believe the recent publication by Amariglio et al, has FDA regulatory implications for the clinical development of therapies based on stem cells.  The under-lined portion of the title of the publication [...]


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		<slash:comments>5</slash:comments>
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		<title>My 2008 Presentations &amp; Articles Relevant to Regenerative Medicine</title>
		<link>http://regenmedguru.com/my-2008-presentations-articles-relevant-to-regenerative-medicine</link>
		<comments>http://regenmedguru.com/my-2008-presentations-articles-relevant-to-regenerative-medicine#comments</comments>
		<pubDate>Sun, 28 Dec 2008 21:49:56 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[4Rs]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[GTPs]]></category>
		<category><![CDATA[OCTGT]]></category>
		<category><![CDATA[cell therapy]]></category>
		<category><![CDATA[Meetings]]></category>
		<category><![CDATA[regenerative medicine]]></category>

		<guid isPermaLink="false">http://regenmedguru.com/?p=48</guid>
		<description><![CDATA[2008 was an extremely busy year for me, as I am sure it was for you as well. The net result is that I have been slow to post updates and thoughts regarding translation of regenerative medicine products to the clinic. In the &#8216;better late than never&#8221; category, I thought I would share some of [...]


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		<slash:comments>4</slash:comments>
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		<title>13 Tips for Successful FDA Meetings</title>
		<link>http://regenmedguru.com/13-tips-for-successful-fda-meetings</link>
		<comments>http://regenmedguru.com/13-tips-for-successful-fda-meetings#comments</comments>
		<pubDate>Mon, 21 Jan 2008 20:30:00 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[OCTGT]]></category>
		<category><![CDATA[Meetings]]></category>

		<guid isPermaLink="false">http://regenmedguru.com/?p=20</guid>
		<description><![CDATA[There are many reasons for meeting with the FDA during development of a regenerative medicine product. Some regenerative medicine products are more novel than others, meaning they are so unique they have never been studied in human clinical trials. Others may not be first of its kind, but may be used in novel clinical applications [...]


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		<slash:comments>1</slash:comments>
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		<item>
		<title>What the Heck is a Regenerative Medicine Therapy?</title>
		<link>http://regenmedguru.com/what-the-heck-is-a-regenerative-medicine-therapy</link>
		<comments>http://regenmedguru.com/what-the-heck-is-a-regenerative-medicine-therapy#comments</comments>
		<pubDate>Mon, 01 Oct 2007 15:37:00 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[4Rs]]></category>
		<category><![CDATA[combination product]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[OCTGT]]></category>
		<category><![CDATA[tissue engineering]]></category>
		<category><![CDATA[combination products]]></category>
		<category><![CDATA[regenerative medicine]]></category>

		<guid isPermaLink="false">http://regenmedguru.com/?p=18</guid>
		<description><![CDATA[My favorite working definition for regenerative medicine is any medical intervention that is intended to repair, replace, restore or regenerate (the 4 R&#8217;s) the cellular, tissue or organ systems in the human body. As described by one of my former FDA colleagues, Dr. Steven Bauer, cellular therapies represent one branch of regenerative medicine that on [...]


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		<slash:comments>1</slash:comments>
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		<title>How Does the FDA View the World of Regenerative Medicine?</title>
		<link>http://regenmedguru.com/how-does-the-fda-view-the-world-of-regenerative-medicine</link>
		<comments>http://regenmedguru.com/how-does-the-fda-view-the-world-of-regenerative-medicine#comments</comments>
		<pubDate>Sun, 01 Jul 2007 20:41:00 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[combination product]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[GTPs]]></category>
		<category><![CDATA[OCTGT]]></category>
		<category><![CDATA[tissue engineering]]></category>
		<category><![CDATA[cell therapy]]></category>
		<category><![CDATA[gene therapy]]></category>
		<category><![CDATA[regenerative medicine]]></category>
		<category><![CDATA[RFD]]></category>

		<guid isPermaLink="false">http://regenmedguru.com/how-does-the-fda-view-the-world-of-regenerative-medicine</guid>
		<description><![CDATA[A major focus of the Regenerative Medicine Guru Blog is the development of new medical interventions based on regenerative medicine. Therefore, it is important to understand how the &#8216;gatekeepers&#8217; view this field. In the U.S., the Food and Drug Administration (FDA) is the key gatekeeper. You may be surprised to learn that there is not [...]


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		<slash:comments>2</slash:comments>
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		<item>
		<title>FDA Regulation of Regenerative Medicine Products</title>
		<link>http://regenmedguru.com/fda-regulation-of-regenerative-medicine-products</link>
		<comments>http://regenmedguru.com/fda-regulation-of-regenerative-medicine-products#comments</comments>
		<pubDate>Fri, 01 Jun 2007 08:11:00 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[combination product]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[OCTGT]]></category>
		<category><![CDATA[tissue engineering]]></category>

		<guid isPermaLink="false">http://regenmedguru.com/?p=3</guid>
		<description><![CDATA[Welcome to the Regenerative Medicine Guru Blog The focus of this blog will be to provide information on how regenerative medicine products are regulated in the U.S. It is intended to be a knowledge portal for those interested in the development of regenerative medicine. We will go in depth into the process to successfully develop [...]


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		<slash:comments>1</slash:comments>
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