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	<title>Regenerative Medicine Guru &#187; combination product</title>
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	<description>The Knowledge Portal to Help Regenerative Medicine Products Reach the Clinic Sooner</description>
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		<title>New FDA Proposed Rule will Impact Regenerative Medicine Products</title>
		<link>http://regenmedguru.com/new-fda-proposed-rule-regen-med</link>
		<comments>http://regenmedguru.com/new-fda-proposed-rule-regen-med#comments</comments>
		<pubDate>Fri, 02 Oct 2009 00:30:16 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[combination product]]></category>
		<category><![CDATA[FDA]]></category>
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		<description><![CDATA[For those involved in creating regenerative medicine products that combine cells with various biomaterials, such as natural or synthetic scaffolds, you should be aware that the FDA recently issued a new Proposed Rule for these types of medical products.  In regulatory speak these are &#8220;combination products&#8221; since each component can be regulated separately.  For example, [...]


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		<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>
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		<category><![CDATA[OCTGT]]></category>
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		<category><![CDATA[combination products]]></category>
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		<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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		<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>
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		<category><![CDATA[cell therapy]]></category>
		<category><![CDATA[gene therapy]]></category>
		<category><![CDATA[regenerative medicine]]></category>
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		<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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		<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>
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		<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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