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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 Calls it a Day</title>
		<link>http://gxpperspectives.com/2012/07/23/gxp-perspectives-calls-it-a-day/</link>
		<comments>http://gxpperspectives.com/2012/07/23/gxp-perspectives-calls-it-a-day/#comments</comments>
		<pubDate>Tue, 24 Jul 2012 05:21:41 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[GxP]]></category>

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		<description><![CDATA[On 13 February 2009 GxP Perspectives came into existence as the fledgling blog, Carl&#8217;s Blog on FDA Stuff. Since then the blog has published 202 additional posts, many by experienced GxP Professionals, and has accumulated 607 email subscribers and 577 members of the GxP Perspectives Linkedin Group. However, putting out a blog takes up a [&#8230;]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4800&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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		<title>Three Things That You Should Know About Part 11</title>
		<link>http://gxpperspectives.com/2012/06/04/three-things-that-you-should-know-about-part-11/</link>
		<comments>http://gxpperspectives.com/2012/06/04/three-things-that-you-should-know-about-part-11/#comments</comments>
		<pubDate>Mon, 04 Jun 2012 21:56:25 +0000</pubDate>
		<dc:creator>GxP Perspectives</dc:creator>
				<category><![CDATA[GxP]]></category>
		<category><![CDATA[Bioresearch Monitoring]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA Enforcement Issues]]></category>
		<category><![CDATA[Part 11]]></category>
		<category><![CDATA[Validation]]></category>

		<guid isPermaLink="false">http://gxpperspectives.com/?p=4790</guid>
		<description><![CDATA[What is FDA doing about Part 11? Is the regulation for electronic records and electronic signatures still in force? &#8211; The answer is YES &#8211; What, if anything, should my company or clinical site be doing about it. Strict compliance can be very expensive- almost as expensive as no compliance at all! Here are three [&#8230;]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=gxpperspectives.com&#038;blog=6610396&#038;post=4790&#038;subd=carl1anderson&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
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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>

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		<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 [&#8230;]<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 [&#8230;]<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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		<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 [&#8230;]<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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		<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 [&#8230;]<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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		<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 [&#8230;]<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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		<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 [&#8230;]<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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		<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>

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		<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 [&#8230;]<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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			<media:title type="html">magnify drug</media:title>
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			<media:title type="html">budapest</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 [&#8230;]<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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			<media:title type="html">Carl&#039;s Blog on FDA Stuff</media:title>
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			<media:title type="html">clinical_trials2</media:title>
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			<media:title type="html">pharmaceutical dice</media:title>
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