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	<title>Regenerative Medicine Guru &#187; regenerative medicine</title>
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	<link>http://regenmedguru.com</link>
	<description>The Knowledge Portal to Help Regenerative Medicine Products Reach the Clinic Sooner</description>
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		<title>FDA issues Complete Response Letter to Fibrocell Science BLA</title>
		<link>http://regenmedguru.com/fda-issues-complete-response-letter-to-fibrocell-science-bla</link>
		<comments>http://regenmedguru.com/fda-issues-complete-response-letter-to-fibrocell-science-bla#comments</comments>
		<pubDate>Sun, 27 Dec 2009 09:15:54 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[regenerative medicine]]></category>
		<category><![CDATA[cell therapy]]></category>
		<category><![CDATA[CMC]]></category>
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		<guid isPermaLink="false">http://regenmedguru.com/?p=147</guid>
		<description><![CDATA[In follow up to an earlier post on Fibrocell Science, Inc., according to the company on 21-December the FDA issued a &#8216;complete response&#8217; letter that identifies the need to provide histopathology biopsy data on patients treated with the autologous fibroblast product as well as to resolve some manufacturing issues (CMC). The details of the letter [...]


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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>ChondroCelect is First Advanced Therapy Medicinal Product Approved in EU</title>
		<link>http://regenmedguru.com/chondrocelect-approval</link>
		<comments>http://regenmedguru.com/chondrocelect-approval#comments</comments>
		<pubDate>Thu, 29 Oct 2009 21:46:40 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[Advanced Therapy Medicinal Product (ATMP)]]></category>
		<category><![CDATA[EMEA]]></category>
		<category><![CDATA[regenerative medicine]]></category>

		<guid isPermaLink="false">http://regenmedguru.com/?p=107</guid>
		<description><![CDATA[For those following the commercialization of regenerative medicine products, there has been some promising news this month. Tigenix, based in Belgium, received authorization on October 09, 2009 from the European Commission to market ChondroCelect, its autologous chondrocyte implantation (ACI) product.  This is the first medicinal product to be approved as an Advanced Therapy Medicinal Product [...]


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		<slash:comments>0</slash:comments>
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		<title>Human Tissues: Never Trust, Always Verify</title>
		<link>http://regenmedguru.com/human-tissues-never-trust-always-verify</link>
		<comments>http://regenmedguru.com/human-tissues-never-trust-always-verify#comments</comments>
		<pubDate>Tue, 27 Oct 2009 23:54:18 +0000</pubDate>
		<dc:creator>Darin</dc:creator>
				<category><![CDATA[]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[GMPs]]></category>
		<category><![CDATA[GTPs]]></category>
		<category><![CDATA[regenerative medicine]]></category>

		<guid isPermaLink="false">http://regenmedguru.com/?p=128</guid>
		<description><![CDATA[On October 13, 2009, the FDA posted on its website a news release from the U.S. Attorney concerning a California man who on multiple occasions falsified records related to the suitability of human tissues for clinical use.  This is unfortunately just one example of problems with those supplying human tissues.  Follow this link to the [...]


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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>
		<category><![CDATA[GMPs]]></category>
		<category><![CDATA[QSRs]]></category>
		<category><![CDATA[regenerative medicine]]></category>

		<guid isPermaLink="false">http://regenmedguru.com/?p=98</guid>
		<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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		<slash:comments>0</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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