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	<title>ParagonRx Blog</title>
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	<link>http://blog.paragonrx.com</link>
	<description>The latest in pharmaceutical appropriate use, risk management &#38; REMS</description>
	<pubDate>Thu, 25 Feb 2010 14:36:14 +0000</pubDate>
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			<item>
		<title>FDLI Conference on REMS: Benefits and Risks Meet Liabilities and Opportunities</title>
		<link>http://blog.paragonrx.com/2010/02/24/fdli-conference-on-rems-benefits-and-risks-meet-liabilities-and-opportunities/</link>
		<comments>http://blog.paragonrx.com/2010/02/24/fdli-conference-on-rems-benefits-and-risks-meet-liabilities-and-opportunities/#comments</comments>
		<pubDate>Thu, 25 Feb 2010 01:41:48 +0000</pubDate>
		<dc:creator>ParagonRx</dc:creator>
		
		<category><![CDATA[Pharmaceuticals]]></category>

		<category><![CDATA[REMS]]></category>

		<category><![CDATA[approval]]></category>

		<category><![CDATA[Drug]]></category>

		<category><![CDATA[EASU]]></category>

		<category><![CDATA[FDA]]></category>

		<category><![CDATA[FDLI]]></category>

		<category><![CDATA[Gary Slatko]]></category>

		<category><![CDATA[NDA]]></category>

		<category><![CDATA[opioids]]></category>

		<category><![CDATA[ParagonRx]]></category>

		<category><![CDATA[risk management]]></category>

		<category><![CDATA[Roger Morris]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=330</guid>
		<description><![CDATA[- Guest blog by Roger Morris, The LondonBritian Company -
You’ve heard all the analogies:  Is the glass half empty or half full?  Does the dark storm cloud have a silver lining?
I was constantly reminded of this during the Food &#38; Drug Law Institute’s latest conference on REMS held February 16 in Washington, D.C., as the [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/02/24/fdli-conference-on-rems-benefits-and-risks-meet-liabilities-and-opportunities/feed/</wfw:commentRss>
		</item>
		<item>
		<title>VIOXX - What Could Have Been in the Age of REMS</title>
		<link>http://blog.paragonrx.com/2010/02/15/vioxx-what-could-have-been-in-the-age-of-rems/</link>
		<comments>http://blog.paragonrx.com/2010/02/15/vioxx-what-could-have-been-in-the-age-of-rems/#comments</comments>
		<pubDate>Mon, 15 Feb 2010 20:56:00 +0000</pubDate>
		<dc:creator>ParagonRx</dc:creator>
		
		<category><![CDATA[REMS]]></category>

		<category><![CDATA[cardiovascular risk]]></category>

		<category><![CDATA[communication plan]]></category>

		<category><![CDATA[EASU]]></category>

		<category><![CDATA[FDA]]></category>

		<category><![CDATA[FDAAA]]></category>

		<category><![CDATA[heart attack]]></category>

		<category><![CDATA[medication]]></category>

		<category><![CDATA[medication guide]]></category>

		<category><![CDATA[merck]]></category>

		<category><![CDATA[NDA]]></category>

		<category><![CDATA[risk management]]></category>

		<category><![CDATA[safety]]></category>

		<category><![CDATA[safety issues]]></category>

		<category><![CDATA[vioxx]]></category>

		<category><![CDATA[wendy kaplan nickel]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=315</guid>
		<description><![CDATA[- Guest blog by Wendy Kaplan Nickel -
Perhaps one of the greatest downfalls in drug history was the steep tumble of VIOXX after it was voluntarily pulled from the market in 2004.  VIOXX was approved by the FDA in 1999 and quickly became &#8220;the&#8221; drug for arthritis.  It gained widespread acceptance among physicians and over [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/02/15/vioxx-what-could-have-been-in-the-age-of-rems/feed/</wfw:commentRss>
		</item>
		<item>
		<title>Are You Attending the FDLI’s Important REMS Conference in Washington?</title>
		<link>http://blog.paragonrx.com/2010/02/05/are-you-attending-the-fdlis-important-rems-conference-in-washington/</link>
		<comments>http://blog.paragonrx.com/2010/02/05/are-you-attending-the-fdlis-important-rems-conference-in-washington/#comments</comments>
		<pubDate>Fri, 05 Feb 2010 18:55:58 +0000</pubDate>
		<dc:creator>ParagonRx</dc:creator>
		
		<category><![CDATA[Pharmaceuticals]]></category>

		<category><![CDATA[REMS]]></category>

		<category><![CDATA[FDA]]></category>

		<category><![CDATA[FDLI]]></category>

		<category><![CDATA[Gary Slatko]]></category>

		<category><![CDATA[ParagonRx]]></category>

		<category><![CDATA[regulatory]]></category>

		<category><![CDATA[REMS program]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=302</guid>
		<description><![CDATA[- Guest blog by  Roger Morris, The LondonBritain Company -
Having worked in communications in the pharmaceutical industry for more than 25 years, I continue to be amazed at how even strong competitors remain so open to sharing information and experiences.  Perhaps it’s the academic nature of pharmaceutical research that filters out to everyone else in [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/02/05/are-you-attending-the-fdlis-important-rems-conference-in-washington/feed/</wfw:commentRss>
		</item>
		<item>
		<title>We&#8217;ve Grown to Better Support Our Clients</title>
		<link>http://blog.paragonrx.com/2010/01/08/weve-grown-to-better-support-our-clients/</link>
		<comments>http://blog.paragonrx.com/2010/01/08/weve-grown-to-better-support-our-clients/#comments</comments>
		<pubDate>Fri, 08 Jan 2010 20:22:11 +0000</pubDate>
		<dc:creator>Jeff Fetterman</dc:creator>
		
		<category><![CDATA[REMS]]></category>

		<category><![CDATA[communication plan]]></category>

		<category><![CDATA[EASU]]></category>

		<category><![CDATA[Elements to Assure Safe Use]]></category>

		<category><![CDATA[NDA]]></category>

		<category><![CDATA[ParagonRx]]></category>

		<category><![CDATA[REMS design]]></category>

		<category><![CDATA[risk management]]></category>

		<category><![CDATA[safety]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=294</guid>
		<description><![CDATA[Since 2003, ParagonRx has helped design, document, or negotiate dozens of risk management programs and REMS for pharmaceutical products.  Clients who choose to work with us have done so because of three operating principles:

We believe in a balanced approach to REMS design in which safety objectives are achieved while preserving commercial viability.
We employ science-based methods [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/01/08/weve-grown-to-better-support-our-clients/feed/</wfw:commentRss>
		</item>
		<item>
		<title>REMS Assessments</title>
		<link>http://blog.paragonrx.com/2009/12/22/rems-assessments/</link>
		<comments>http://blog.paragonrx.com/2009/12/22/rems-assessments/#comments</comments>
		<pubDate>Tue, 22 Dec 2009 21:50:28 +0000</pubDate>
		<dc:creator>Kevin Fetterman</dc:creator>
		
		<category><![CDATA[REMS]]></category>

		<category><![CDATA[communication plan]]></category>

		<category><![CDATA[draft guidance]]></category>

		<category><![CDATA[FDA]]></category>

		<category><![CDATA[FDAAA]]></category>

		<category><![CDATA[guidance]]></category>

		<category><![CDATA[medication]]></category>

		<category><![CDATA[medication guide]]></category>

		<category><![CDATA[ParagonRx]]></category>

		<category><![CDATA[Proposed REMS]]></category>

		<category><![CDATA[REMS assessment]]></category>

		<category><![CDATA[REMS design]]></category>

		<category><![CDATA[risk evaluation]]></category>

		<category><![CDATA[risk management]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=289</guid>
		<description><![CDATA[As we advise clients about REMS design and implementation, the most frequent concern we encounter is related to REMS assessment.  A look at the math reveals why this is so.  Over 63 REMS have been approved since FDAAA statutes for REMS became effective in March 2008.  Of those, more than 90% are comprised of Medication [...]]]></description>
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		</item>
		<item>
		<title>FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance – A Preliminary Review (Part V)</title>
		<link>http://blog.paragonrx.com/2009/10/15/fdas-draft-rems-guidance-a-preliminary-review-part-5/</link>
		<comments>http://blog.paragonrx.com/2009/10/15/fdas-draft-rems-guidance-a-preliminary-review-part-5/#comments</comments>
		<pubDate>Thu, 15 Oct 2009 18:47:23 +0000</pubDate>
		<dc:creator>Gary Slatko</dc:creator>
		
		<category><![CDATA[Pharmaceuticals]]></category>

		<category><![CDATA[REMS]]></category>

		<category><![CDATA[approval]]></category>

		<category><![CDATA[benefit-risk]]></category>

		<category><![CDATA[EASU]]></category>

		<category><![CDATA[Elements to Assure Safe Use]]></category>

		<category><![CDATA[evidence-based]]></category>

		<category><![CDATA[FDA]]></category>

		<category><![CDATA[FDAAA]]></category>

		<category><![CDATA[guidance]]></category>

		<category><![CDATA[medication]]></category>

		<category><![CDATA[medication guide]]></category>

		<category><![CDATA[NDA]]></category>

		<category><![CDATA[Proposed REMS]]></category>

		<category><![CDATA[REMS assessment]]></category>

		<category><![CDATA[REMS design]]></category>

		<category><![CDATA[REMS development]]></category>

		<category><![CDATA[REMS effectiveness]]></category>

		<category><![CDATA[REMS elements]]></category>

		<category><![CDATA[REMS guidance]]></category>

		<category><![CDATA[REMS program]]></category>

		<category><![CDATA[REMS supporting document]]></category>

		<category><![CDATA[risk assessment]]></category>

		<category><![CDATA[risk evaluation]]></category>

		<category><![CDATA[Risk Evaluation and Mitigation Strategy]]></category>

		<category><![CDATA[risk management]]></category>

		<category><![CDATA[RiskMAP]]></category>

		<category><![CDATA[submission]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=239</guid>
		<description><![CDATA[Our first four articles covered the background of FDAAA and REMS, an overview of a REMS submission and greater detail about the “Proposed REMS” and “REMS Supporting Document”, and REMS submissions and communications with FDA.
In this fifth and final article, we address our preliminary interpretation of the draft guidance, as well as opportunities for industry to respond and propose further improvements.]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2009/10/15/fdas-draft-rems-guidance-a-preliminary-review-part-5/feed/</wfw:commentRss>
		</item>
		<item>
		<title>FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance – A Preliminary Review (Part IV)</title>
		<link>http://blog.paragonrx.com/2009/10/13/fdas-draft-rems-guidance-a-preliminary-review-part-4/</link>
		<comments>http://blog.paragonrx.com/2009/10/13/fdas-draft-rems-guidance-a-preliminary-review-part-4/#comments</comments>
		<pubDate>Tue, 13 Oct 2009 15:23:08 +0000</pubDate>
		<dc:creator>Gary Slatko</dc:creator>
		
		<category><![CDATA[Pharmaceuticals]]></category>

		<category><![CDATA[REMS]]></category>

		<category><![CDATA[approval]]></category>

		<category><![CDATA[approved REMS]]></category>

		<category><![CDATA[biologics]]></category>

		<category><![CDATA[FDA]]></category>

		<category><![CDATA[FDAAA]]></category>

		<category><![CDATA[generic drug]]></category>

		<category><![CDATA[guidance]]></category>

		<category><![CDATA[Proposed REMS]]></category>

		<category><![CDATA[regulatory]]></category>

		<category><![CDATA[REMS assessment]]></category>

		<category><![CDATA[REMS document]]></category>

		<category><![CDATA[REMS elements]]></category>

		<category><![CDATA[REMS guidance]]></category>

		<category><![CDATA[REMS supporting document]]></category>

		<category><![CDATA[risk evaluation]]></category>

		<category><![CDATA[Risk Evaluation and Mitigation Strategy]]></category>

		<category><![CDATA[submission]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=228</guid>
		<description><![CDATA[Our first three articles covered the background of FDAAA and REMS, an overview of a REMS submission and greater detail about the “Proposed REMS”, and “REMS Supporting Document” components of the REMS document submission. This article covers the section of the guidance about “REMS assessment and modification submissions” and “communicating with FDA”.]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2009/10/13/fdas-draft-rems-guidance-a-preliminary-review-part-4/feed/</wfw:commentRss>
		</item>
		<item>
		<title>FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance – A Preliminary Review (Part III)</title>
		<link>http://blog.paragonrx.com/2009/10/07/fdas-draft-rems-guidance-a-preliminary-review-part-3/</link>
		<comments>http://blog.paragonrx.com/2009/10/07/fdas-draft-rems-guidance-a-preliminary-review-part-3/#comments</comments>
		<pubDate>Wed, 07 Oct 2009 19:51:50 +0000</pubDate>
		<dc:creator>Gary Slatko</dc:creator>
		
		<category><![CDATA[Pharmaceuticals]]></category>

		<category><![CDATA[REMS]]></category>

		<category><![CDATA[approval]]></category>

		<category><![CDATA[EASU]]></category>

		<category><![CDATA[Elements to Assure Safe Use]]></category>

		<category><![CDATA[FDA]]></category>

		<category><![CDATA[FDAAA]]></category>

		<category><![CDATA[guidance]]></category>

		<category><![CDATA[medication]]></category>

		<category><![CDATA[medication guide]]></category>

		<category><![CDATA[Proposed REMS]]></category>

		<category><![CDATA[regulatory]]></category>

		<category><![CDATA[REMS approval]]></category>

		<category><![CDATA[REMS assessment]]></category>

		<category><![CDATA[REMS document]]></category>

		<category><![CDATA[REMS elements]]></category>

		<category><![CDATA[REMS supporting document]]></category>

		<category><![CDATA[risk evaluation]]></category>

		<category><![CDATA[Risk Evaluation and Mitigation Strategy]]></category>

		<category><![CDATA[risk management]]></category>

		<category><![CDATA[RiskMAP]]></category>

		<category><![CDATA[safety]]></category>

		<category><![CDATA[submission]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=203</guid>
		<description><![CDATA[Our first two articles covered the background of FDAAA and REMS relative to RiskMAPs and those RiskMAPs deemed to be REMS, an overview of a REMS submission, and greater detail about the more concise “proposed REMS” component of the REMS document submission. This article details the content of the more comprehensive “REMS Supporting Document”, which explains the rationale for, and supporting information about, the proposed REMS.]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2009/10/07/fdas-draft-rems-guidance-a-preliminary-review-part-3/feed/</wfw:commentRss>
		</item>
		<item>
		<title>FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance – A Preliminary Review (Part II)</title>
		<link>http://blog.paragonrx.com/2009/10/05/fdas-draft-rems-guidance-a-preliminary-review-part-2/</link>
		<comments>http://blog.paragonrx.com/2009/10/05/fdas-draft-rems-guidance-a-preliminary-review-part-2/#comments</comments>
		<pubDate>Mon, 05 Oct 2009 18:42:48 +0000</pubDate>
		<dc:creator>Gary Slatko</dc:creator>
		
		<category><![CDATA[Pharmaceuticals]]></category>

		<category><![CDATA[REMS]]></category>

		<category><![CDATA[communication plan]]></category>

		<category><![CDATA[EASU]]></category>

		<category><![CDATA[Elements to Assure Safe Use]]></category>

		<category><![CDATA[FDA]]></category>

		<category><![CDATA[FDAAA]]></category>

		<category><![CDATA[guidance]]></category>

		<category><![CDATA[medication]]></category>

		<category><![CDATA[medication guide]]></category>

		<category><![CDATA[NDA]]></category>

		<category><![CDATA[Proposed REMS]]></category>

		<category><![CDATA[REMS assessment]]></category>

		<category><![CDATA[REMS document]]></category>

		<category><![CDATA[REMS elements]]></category>

		<category><![CDATA[REMS supporting document]]></category>

		<category><![CDATA[risk evaluation]]></category>

		<category><![CDATA[Risk Evaluation and Mitigation Strategy]]></category>

		<category><![CDATA[RiskMAP]]></category>

		<category><![CDATA[safety]]></category>

		<category><![CDATA[submission]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=190</guid>
		<description><![CDATA[On September 30th, FDA issued its long awaited draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”. While much of this draft guidance is a codification of what’s already been happening in practice over the past two years,   there are a few interesting [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2009/10/05/fdas-draft-rems-guidance-a-preliminary-review-part-2/feed/</wfw:commentRss>
		</item>
		<item>
		<title>FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance - A Preliminary Review (Part I)</title>
		<link>http://blog.paragonrx.com/2009/09/30/fdas-draft-rems-guidance-a-preliminary-review-part-1/</link>
		<comments>http://blog.paragonrx.com/2009/09/30/fdas-draft-rems-guidance-a-preliminary-review-part-1/#comments</comments>
		<pubDate>Wed, 30 Sep 2009 21:47:26 +0000</pubDate>
		<dc:creator>Gary Slatko</dc:creator>
		
		<category><![CDATA[Pharmaceuticals]]></category>

		<category><![CDATA[REMS]]></category>

		<category><![CDATA[approved REMS]]></category>

		<category><![CDATA[communication plan]]></category>

		<category><![CDATA[deemed REMS]]></category>

		<category><![CDATA[EASU]]></category>

		<category><![CDATA[Elements to Assure Safe Use]]></category>

		<category><![CDATA[FDA]]></category>

		<category><![CDATA[FDAAA]]></category>

		<category><![CDATA[guidance]]></category>

		<category><![CDATA[medication]]></category>

		<category><![CDATA[medication guide]]></category>

		<category><![CDATA[NDA]]></category>

		<category><![CDATA[Proposed REMS]]></category>

		<category><![CDATA[regulatory]]></category>

		<category><![CDATA[REMS assessment]]></category>

		<category><![CDATA[REMS document]]></category>

		<category><![CDATA[REMS guidance]]></category>

		<category><![CDATA[REMS supporting document]]></category>

		<category><![CDATA[risk evaluation]]></category>

		<category><![CDATA[Risk Evaluation and Mitigation Strategy]]></category>

		<category><![CDATA[risk management]]></category>

		<category><![CDATA[RiskMAP]]></category>

		<category><![CDATA[safety]]></category>

		<category><![CDATA[submission]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=175</guid>
		<description><![CDATA[FDA issued its long awaited draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”, on September 30. While much of the guidance is codification of what’s already been happening in practice over the past two years, there are a few surprises (indicated here in bold) [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2009/09/30/fdas-draft-rems-guidance-a-preliminary-review-part-1/feed/</wfw:commentRss>
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