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	<title>GxP Perspectives</title>
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	<description>Commentary on FDA, clinical trials, research ethics, GCP, drug safety, and FDA Warning Letters</description>
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		<title>GxP Perspectives</title>
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		<title>FDA &amp; EMA Regulatory Developments for eSubmissions</title>
		<link>http://gxpperspectives.com/2012/05/14/fda-ema-regulatory-developments-for-esubmissions/</link>
		<comments>http://gxpperspectives.com/2012/05/14/fda-ema-regulatory-developments-for-esubmissions/#comments</comments>
		<pubDate>Tue, 15 May 2012 04:01:02 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[Clinical Trials]]></category>
		<category><![CDATA[EMA]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA eSubmissions]]></category>
		<category><![CDATA[health]]></category>
		<category><![CDATA[Health Canada]]></category>

		<guid isPermaLink="false">http://gxpperspectives.com/?p=4771</guid>
		<description><![CDATA[A few months ago, GxP Perspectives discussed eCTD as a Required Format for FDA Submissions. To summarize, in PDUFA V Commitment Letter 8-31-2011, the agency announced their intention of issuing draft guidance for required electronic submissions in eCTD format by December 31, 2012, with final guidance no more than 12 months after the close of [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4771&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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		<title>FDA IP Labeling Requirements</title>
		<link>http://gxpperspectives.com/2012/04/29/4739/</link>
		<comments>http://gxpperspectives.com/2012/04/29/4739/#comments</comments>
		<pubDate>Mon, 30 Apr 2012 02:55:16 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[Clinical Trials]]></category>
		<category><![CDATA[Drug Labels]]></category>
		<category><![CDATA[Drug Safety]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[GCP]]></category>
		<category><![CDATA[public health]]></category>

		<guid isPermaLink="false">http://gxpperspectives.com/?p=4739</guid>
		<description><![CDATA[What are FDA’s requirements for labeling investigational drug and biological products (IP)? We are all aware of the required statement in 21 CFR 312.6, &#8220;(a) The immediate package of an investigational new drug intended for human use shall bear a label with the statement &#8216;Caution: New Drug&#8211;Limited by Federal (or United States) law to investigational [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4739&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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			<media:title type="html">Carl&#039;s Blog on FDA Stuff</media:title>
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		<title>Quantifying Quality for GxP Compliance</title>
		<link>http://gxpperspectives.com/2012/04/08/quantifying-quality-for-gxp-compliance/</link>
		<comments>http://gxpperspectives.com/2012/04/08/quantifying-quality-for-gxp-compliance/#comments</comments>
		<pubDate>Sun, 08 Apr 2012 18:36:42 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[GxP]]></category>
		<category><![CDATA[public health]]></category>
		<category><![CDATA[Quality Assurance]]></category>
		<category><![CDATA[quantifying quality]]></category>

		<guid isPermaLink="false">http://gxpperspectives.com/?p=4708</guid>
		<description><![CDATA[GxP professionals understand the need for quality and quality system and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? Once again we turn to Len Grunbaum and Emma Barsky, regular contributors to GxP Perspectives, for their insight on how to quantify [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4708&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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			<media:title type="html">Carl&#039;s Blog on FDA Stuff</media:title>
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			<media:title type="html">Q</media:title>
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		<title>FDA &amp; Politics: In the Interest of Science?</title>
		<link>http://gxpperspectives.com/2012/04/03/fda-politics-in-the-interest-of-science/</link>
		<comments>http://gxpperspectives.com/2012/04/03/fda-politics-in-the-interest-of-science/#comments</comments>
		<pubDate>Tue, 03 Apr 2012 16:38:43 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[Consumer protection]]></category>
		<category><![CDATA[Margaret Hamburg]]></category>
		<category><![CDATA[public health]]></category>
		<category><![CDATA[Science and Politics]]></category>

		<guid isPermaLink="false">http://gxpperspectives.com/?p=4691</guid>
		<description><![CDATA[FDA Regulates 25% of the U.S. economy and has long been the target of lobbyists from the food,drug, &#38; tobacco industries.The question is always asked: &#8220;Is mixing the public health mission of FDA with politics in the current political climate advancing the interests of the American consumer?&#8221; Unfortunately, the answer is almost always no. Last [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4691&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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			<media:title type="html">Carl&#039;s Blog on FDA Stuff</media:title>
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			<media:title type="html">Andrew Von Eschenbach</media:title>
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		<title>TMF Reference Model Update</title>
		<link>http://gxpperspectives.com/2012/03/18/tmf-reference-model-update/</link>
		<comments>http://gxpperspectives.com/2012/03/18/tmf-reference-model-update/#comments</comments>
		<pubDate>Sun, 18 Mar 2012 17:28:32 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[GCP]]></category>
		<category><![CDATA[Clinical Trials]]></category>
		<category><![CDATA[TMF]]></category>
		<category><![CDATA[trial master file]]></category>

		<guid isPermaLink="false">http://gxpperspectives.com/?p=4672</guid>
		<description><![CDATA[The recommended and required contents of the TMF, the trial master file, continue to be a concern for clinical trial professionals. This blog continues to support the efforts of the DIA working group for the TMF Reference Model, originally issued in 2010. The most recent updates to the TMF RM within Version 1.2, which was [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4672&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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		<slash:comments>1</slash:comments>
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			<media:title type="html">Carl&#039;s Blog on FDA Stuff</media:title>
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			<media:title type="html">file cabinets</media:title>
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			<media:title type="html">clinicalTrials_0_0</media:title>
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		<title>India: Quality for Clinical Trials</title>
		<link>http://gxpperspectives.com/2012/03/01/india-quality-for-clinical-trials/</link>
		<comments>http://gxpperspectives.com/2012/03/01/india-quality-for-clinical-trials/#comments</comments>
		<pubDate>Thu, 01 Mar 2012 17:50:58 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[Clinical Trials]]></category>
		<category><![CDATA[GCP]]></category>
		<category><![CDATA[Drug Safety]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[India clinical trials]]></category>
		<category><![CDATA[Quality Systems]]></category>

		<guid isPermaLink="false">http://gxpperspectives.com/?p=4652</guid>
		<description><![CDATA[Are Quality Systems in place in India, where the clinical trials industry is exploding?Do clinical trials professionals have the knowledge, skills and experience to run clinical trials where the rights, safety, &#38; welfare of human subjects is protected and where data are reliable for submission to FDA and EMA&#62; In this Guest Commentary QA professional [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4652&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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			<media:title type="html">Carl&#039;s Blog on FDA Stuff</media:title>
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			<media:title type="html">IndiaF</media:title>
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			<media:title type="html">Quality 1</media:title>
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			<media:title type="html">ISO</media:title>
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		<item>
		<title>European Qualified Persons &amp; New EU Anti-Falsification Legislation</title>
		<link>http://gxpperspectives.com/2012/02/07/european-qualified-persons-face-new-eu-anti-falsification-legislation/</link>
		<comments>http://gxpperspectives.com/2012/02/07/european-qualified-persons-face-new-eu-anti-falsification-legislation/#comments</comments>
		<pubDate>Tue, 07 Feb 2012 16:55:02 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[GxP]]></category>
		<category><![CDATA[Drug Safety]]></category>
		<category><![CDATA[EU anti-falsification legislation]]></category>
		<category><![CDATA[GMP]]></category>
		<category><![CDATA[Qualified Persons]]></category>

		<guid isPermaLink="false">http://gxpperspectives.com/?p=4627</guid>
		<description><![CDATA[In the European Union an EU certified &#8220;Qualified Person&#8221; or QP must certify that any batch of medicinal product is in compliance with applicable regulations before it can be released for sale or distribution. Although originally intended for Good Manufacturing Practice, the requirement for QP oversight is now in place for pharmacovigilance and drug products [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4627&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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			<media:title type="html">Carl&#039;s Blog on FDA Stuff</media:title>
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			<media:title type="html">EU Flags</media:title>
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		<title>Drug Accountability in Clinical Trials</title>
		<link>http://gxpperspectives.com/2012/01/19/drug-accountability-in-clinical-trials/</link>
		<comments>http://gxpperspectives.com/2012/01/19/drug-accountability-in-clinical-trials/#comments</comments>
		<pubDate>Thu, 19 Jan 2012 13:23:55 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[Clinical Trials]]></category>
		<category><![CDATA[drug accountability]]></category>
		<category><![CDATA[Drugs]]></category>
		<category><![CDATA[FDA Enforcement Issues]]></category>
		<category><![CDATA[public health]]></category>

		<guid isPermaLink="false">http://gxpperspectives.com/?p=4617</guid>
		<description><![CDATA[Drug Accountability Is the one thing that everyone looks at and everyone ignores in clinical trials. I don&#8217;t know how many times I have read in a monitor&#8217;s report that &#8220;drug accountability not done due to time restraints.&#8221; Yet consistently &#8220;test article accountability&#8221; (as FDA refers to it) is one of the top findings on [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4617&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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		<title>FDA Warning Letters for International APIs in 2011</title>
		<link>http://gxpperspectives.com/2012/01/08/fda-warning-letters-for-international-apis-in-2011/</link>
		<comments>http://gxpperspectives.com/2012/01/08/fda-warning-letters-for-international-apis-in-2011/#comments</comments>
		<pubDate>Mon, 09 Jan 2012 04:15:54 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[active pharmaceutical ingredient]]></category>
		<category><![CDATA[API]]></category>
		<category><![CDATA[Drug Safety]]></category>
		<category><![CDATA[FDA Warning Letters]]></category>

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		<description><![CDATA[FDA issued at least ten Warning Letters to international manufacturers of active pharmaceutical ingredients in FY-2011. Manufacturers in both China and India, the world’s largest exporters of APIs, received three Warning Letters each from FDA. Manufacturers in Spain, the UK, Canada, and Japan each received one Warning Letter from FDA. These metrics show both the [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4600&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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		<title>Commentary on Plan B Controversy</title>
		<link>http://gxpperspectives.com/2011/12/28/commentary-on-plan-b-controversy/</link>
		<comments>http://gxpperspectives.com/2011/12/28/commentary-on-plan-b-controversy/#comments</comments>
		<pubDate>Wed, 28 Dec 2011 18:18:16 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[FDA commentaries]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Kathleen Sebelius]]></category>
		<category><![CDATA[Plan B]]></category>
		<category><![CDATA[public health]]></category>
		<category><![CDATA[Reproductive Health]]></category>

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		<description><![CDATA[Plan B is an emergency contraceptive, sometimes called &#8220;the morning after pill,&#8221; that has been approved as safe and effective for its intended use by the Food and Drug Administration. The drug&#8217;s safety is pretty much beyond dispute. However, it is access to Plan B that is proving controversial. In question is whether Plan B [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4589&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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