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		<title>Articles from the PHG Foundation Newsletter</title>
		<link>http://www.phgfoundation.org/newsletter</link>
		<description>Articles from the PHG Foundation Newsletter</description>
		<copyright>PHG Foundation</copyright>
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			<title>US issues professional guidance on genomic testing</title>
			<link>http://www.phgfoundation.org/news/month/04/2012/#story_11646</link>
			<pubDate>Wed, 11 Apr 2012 00:00:00 +0100</pubDate>
			<description><![CDATA[ The American College of Medical Genetics and Genomics (ACMG) has released a new Policy Statement on Genomic Sequencing.  Points to Consider in the Clinical Application of Genomic Sequencing sets out recommended guidelines for doctors highlighting situations where testing is likely to be most useful  ... ]]></description>
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				<item>
			<title>Portable legal consent framework for genomic research</title>
			<link>http://www.phgfoundation.org/news/month/04/2012/#story_11584</link>
			<pubDate>Thu, 05 Apr 2012 00:00:00 +0100</pubDate>
			<description><![CDATA[ &amp;nbsp;The PLC-CGR, piloted by Sage Bionetworks and collaborators, is the first tool within the Consent to Research project, which also aims to produce user engagement and data storage and access systems for common genomic research ]]></description>
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				<item>
			<title>Oversight needed for clinical translation of genome-based tests</title>
			<link>http://www.phgfoundation.org/news/month/03/2012/#story_11528</link>
			<pubDate>Wed, 28 Mar 2012 00:00:00 +0100</pubDate>
			<description><![CDATA[ The Institute of Medicine (IOM) in the US has released a new report calling for an evaluation process to assess whether &amp;lsquo;omics-based&amp;rsquo; tests are valid and ready for clinical use.  &amp;nbsp;  Genome-Based Diagnostics: Clarifying Pathways to Clinical Use is the report from workshops on transla ... ]]></description>
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			<title>Should oversight of US gene therapy trials change?</title>
			<link>http://www.phgfoundation.org/news/month/03/2012/#story_11466</link>
			<pubDate>Mon, 19 Mar 2012 00:00:00 +0000</pubDate>
			<description><![CDATA[ As the number of gene therapy trials continues to expand, with more than 1150 separate trials in progress in the US alone, American gene therapy experts have said it is time to moderate regulatory oversight.  &amp;nbsp;  Currently, gene therapy clinical trials in the US require review by the federal Rec ... ]]></description>
		</item>
				<item>
			<title>Rapid growth of genetic testing in US despite lack of evidence</title>
			<link>http://www.phgfoundation.org/news/month/03/2012/#story_11452</link>
			<pubDate>Fri, 16 Mar 2012 00:00:00 +0000</pubDate>
			<description><![CDATA[ The US National Institutes of Health (NIH) has opened an online&amp;nbsp;Genetic Testing Registry (GTR), containing information on the availability, validity and usefulness of genetic tests provided by the test providers.  &amp;nbsp;  Plans for the GTR were announced last year (see previous news); it is int ... ]]></description>
		</item>
				<item>
			<title>China and the US act on illegal stem cell treatments</title>
			<link>http://www.phgfoundation.org/news/month/01/2012/#story_10994</link>
			<pubDate>Mon, 16 Jan 2012 00:00:00 +0000</pubDate>
			<description><![CDATA[ The US Food and Drug Administration (FDA) has issued a warning against unregulated stem cell therapeutics.  &amp;nbsp;  In a statement, the regulator reminded the public to avoid any stem cell treatment that was not approved or under officially sanctioned investigation, noting that only one product (Hem ... ]]></description>
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				<item>
			<title>Drivers and barriers for companion diagnostics</title>
			<link>http://www.phgfoundation.org/news/month/01/2012/#story_10897</link>
			<pubDate>Thu, 05 Jan 2012 00:00:00 +0000</pubDate>
			<description><![CDATA[ The importance of companion diagnostic development and approval as an essential corollary to the development of stratified medicines continues to attract attention.  &amp;nbsp;  In July 2011, US regulator the FDA announced that approval of new forms of stratified medicines was likely to require simultan ... ]]></description>
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			<title>Consultation on simplifying UK medicines legislation</title>
			<link>http://www.phgfoundation.org/news/month/01/2012/#story_10888</link>
			<pubDate>Wed, 04 Jan 2012 00:00:00 +0000</pubDate>
			<description><![CDATA[ This review is part of a laudable process to simplify regulation and make it easier for companies and other organisations to understand and comply with legal requirements in this area. It comes at a time when smaller pharmaceutical and biotechnology companies are reportedly increasingly outsourcing  ... ]]></description>
		</item>
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			<title>UK health research regulation to boost patient involvement</title>
			<link>http://www.phgfoundation.org/news/month/12/2011/#story_10714</link>
			<pubDate>Sun, 04 Dec 2011 00:00:00 +0000</pubDate>
			<description><![CDATA[ The&amp;nbsp;UK government has launched the new Health Research Authority&amp;nbsp;(HRA), charged with protecting and promoting the interests of patients and the public in health research.  &amp;nbsp;  The HRA has been formed under government plans to streamline health research regulation. It is intended that t ... ]]></description>
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			<title>Proposals to pay UK women to donate eggs for research</title>
			<link>http://www.phgfoundation.org/news/month/10/2011/#story_10305</link>
			<pubDate>Tue, 18 Oct 2011 00:00:00 +0100</pubDate>
			<description><![CDATA[ Following on from a new stem cell paper for which the researchers obtained large numbers of human oocytes (egg cells) by paying donors (see previous news), the Nuffield Council on Bioethics has said that women donors should be paid in the UK too.  In fact the US payments are limited to financial com ... ]]></description>
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			<title>Clinical trial rules 'hampering research'</title>
			<link>http://www.phgfoundation.org/news/month/10/2011/#story_10164</link>
			<pubDate>Wed, 05 Oct 2011 00:00:00 +0100</pubDate>
			<description><![CDATA[ The group recommends a proportionate approach to the assessment and regulatory requirements of clinical trials that takes into account previous experience with the agent being tested and the patient population. These proposals seem to strike a reasonable balance between maintaining the safety of tri ... ]]></description>
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			<title>Germany rules on ethics of human-animal hybrids</title>
			<link>http://www.phgfoundation.org/news/month/10/2011/#story_10110</link>
			<pubDate>Mon, 03 Oct 2011 00:00:00 +0100</pubDate>
			<description><![CDATA[ The German Ethics Council has issued recommendations on the use of animals containing human material (ACHM).  &amp;nbsp;  The report on this issue reportedly takes an in-depth and philosophical view of what counts as human and which genetic alterations involving animal material constitute a violation of ... ]]></description>
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			<title>New European science policy body to represent researchers</title>
			<link>http://www.phgfoundation.org/news/month/09/2011/#story_9813</link>
			<pubDate>Thu, 08 Sep 2011 00:00:00 +0100</pubDate>
			<description><![CDATA[ A new organisation to be launched next month aims to become the single voice for science policy in Europe.&amp;nbsp;ScienceEurope, to be launched on 21st October, will be based in Brussels and combines two existing groups, the European Science Foundation (ESF) based in France (see previous news) and the ... ]]></description>
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			<title>FDA plans ahead for personalised and genomic medicine</title>
			<link>http://www.phgfoundation.org/news/month/08/2011/#story_9591</link>
			<pubDate>Fri, 19 Aug 2011 00:00:00 +0100</pubDate>
			<description><![CDATA[ New guidance on making applications for the approval of genomic, proteomic, and imaging-based biomarkers, and on how medical device applications are assessed (including consideration of the companion diagnostics) has also been released by the regulator this month. ]]></description>
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			<title>UK strategy for regenerative and cellular medicine unveiled</title>
			<link>http://www.phgfoundation.org/news/month/07/2011/#story_9329</link>
			<pubDate>Fri, 29 Jul 2011 00:00:00 +0100</pubDate>
			<description><![CDATA[ A new government report has set out the challenges for regenerative medicine in the UK and a strategy for future development.  Published by the Office for Life Sciences and the Department of Health (DH), the new report provides an overview of the UK&amp;rsquo;s strengths and weaknesses in regenerative m ... ]]></description>
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			<title>More oversight needed for animals containing human material</title>
			<link>http://www.phgfoundation.org/news/month/07/2011/#story_9267</link>
			<pubDate>Tue, 26 Jul 2011 00:00:00 +0100</pubDate>
			<description><![CDATA[ The Academy of Medical Sciences (AMS) has called for more sensitive oversight of some forms of research involving animals containing human material (ACHM).  &amp;nbsp;  A new AMS report has said that, whilst most such research (for example, using genetically modified mice that contain a human gene or ge ... ]]></description>
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			<title>A regulatory framework for sequencing based diagnostics</title>
			<link>http://www.phgfoundation.org/news/month/07/2011/#story_9183</link>
			<pubDate>Fri, 15 Jul 2011 00:00:00 +0100</pubDate>
			<description><![CDATA[ The number of NGS platforms, differences in their performance metrics and the applications they can be used for, ranging from whole genome sequencing to targeted gene sequencing, can make evaluation difficult. In addition, this is a dynamic field meaning that any framework will have to be flexible t ... ]]></description>
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			<title>FDA proposals on regulation of stratified medicines</title>
			<link>http://www.phgfoundation.org/news/month/07/2011/#story_9133</link>
			<pubDate>Thu, 14 Jul 2011 00:00:00 +0100</pubDate>
			<description><![CDATA[ The US Food and Drug Administration (FDA) has called for feedback on new proposals to govern the regulation of biologically targeted treatments, also referred to as stratified medicines.  &amp;nbsp;  Treatments such as these are suitable for use in only a sub-group of patients with a given disease, beca ... ]]></description>
		</item>
				<item>
			<title>Geneticists' opposition to direct-to-consumer genetic tests</title>
			<link>http://www.phgfoundation.org/news/month/06/2011/#story_8708</link>
			<pubDate>Mon, 06 Jun 2011 00:00:00 +0100</pubDate>
			<description><![CDATA[ A survey of European clinical geneticists has revealed opposition to direct-to-consumer (DTC) genetic testing.  &amp;nbsp;  Of the 131 respondents to the University of Leuven study, 90% reportedly felt that predictive DTC genetic testing should require direct medical supervision (ie. not really be DTC). ... ]]></description>
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				<item>
			<title>French conservatives fight back against embryo research</title>
			<link>http://www.phgfoundation.org/news/month/05/2011/#story_8659</link>
			<pubDate>Sat, 28 May 2011 00:00:00 +0100</pubDate>
			<description><![CDATA[ Many researchers are keen to press ahead with human embryonic stem-cell research, and will be frustrated by this turn of events. However, as the vote clearly demonstrated, many people in France have profound ethical concerns about the use of human embryos and cell lines, even for medical research, f ... ]]></description>
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