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	<title>Good Reprint Practices</title>
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	<description>Get a fresh look at FDA regulation of off-label information</description>
	<pubDate>Thu, 29 Jul 2010 17:03:49 +0000</pubDate>
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		<title>Waxman Staffer Returning to FDA</title>
		<link>http://www.goodreprintpractices.com/2009/10/waxman-staffer-returning-to-fda/</link>
		<comments>http://www.goodreprintpractices.com/2009/10/waxman-staffer-returning-to-fda/#comments</comments>
		<pubDate>Fri, 16 Oct 2009 20:29:34 +0000</pubDate>
		<dc:creator>John</dc:creator>
		
		<category><![CDATA[Featured Articles]]></category>

		<guid isPermaLink="false">http://www.goodreprintpractices.com/?p=270</guid>
		<description><![CDATA[According to the Pink Sheet, Ann Witt a former Acting Director of DDMAC (or its predecessor organization, I can&#8217;t remember the name) is returning to the FDA in CDER&#8217;s Office of Policy, Planning and Budget.  Ms. Witt was a key staffer for Waxman, who you might recall very vocally questioned the substance and guidance making [...]]]></description>
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		<title>FDA Issues Untitled Letter on Reprint Carrier</title>
		<link>http://www.goodreprintpractices.com/2009/05/fda-issues-untitled-letter-on-reprint-carrier/</link>
		<comments>http://www.goodreprintpractices.com/2009/05/fda-issues-untitled-letter-on-reprint-carrier/#comments</comments>
		<pubDate>Thu, 14 May 2009 15:22:02 +0000</pubDate>
		<dc:creator>John</dc:creator>
		
		<category><![CDATA[Featured Articles]]></category>

		<guid isPermaLink="false">http://www.goodreprintpractices.com/?p=250</guid>
		<description><![CDATA[In an untitled letter dated April 16, 2009, FDA&#8217;s Division of Drug Marketing, Advertising and Communications warned Sanofi Aventis about what it alleges are unsubstantiated claims about the oncology product Taxotere on a reprint carrier.  The letter includes fairly common objections of unsubstantiated superiority claims and overstatements of efficacy. For those of us practiced in the [...]]]></description>
		<wfw:commentRss>http://www.goodreprintpractices.com/2009/05/fda-issues-untitled-letter-on-reprint-carrier/feed/</wfw:commentRss>
		</item>
		<item>
		<title>Sidetrack:  FDA Takes on Internet Promotion</title>
		<link>http://www.goodreprintpractices.com/2009/04/sidetrack-fda-takes-on-internet-promotion/</link>
		<comments>http://www.goodreprintpractices.com/2009/04/sidetrack-fda-takes-on-internet-promotion/#comments</comments>
		<pubDate>Mon, 06 Apr 2009 22:16:05 +0000</pubDate>
		<dc:creator>John</dc:creator>
		
		<category><![CDATA[Archives]]></category>

		<category><![CDATA[DDMAC and sponsored links]]></category>

		<category><![CDATA[DDMAC internet letters]]></category>

		<category><![CDATA[ddmac warning letters]]></category>

		<category><![CDATA[fair balance]]></category>

		<category><![CDATA[FDA and internet promotion]]></category>

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

		<category><![CDATA[FDA social media guidance]]></category>

		<category><![CDATA[Google sponsored links and FDA]]></category>

		<category><![CDATA[internet advertising]]></category>

		<category><![CDATA[internet links and DDMAC]]></category>

		<category><![CDATA[Internet links and FDA]]></category>

		<category><![CDATA[Yahoo sponsored links and Yahoo]]></category>

		<guid isPermaLink="false">http://www.goodreprintpractices.com/?p=219</guid>
		<description><![CDATA[Friday, FDA&#8217;s Division of Drug Marketing, Advertising and Communications posted 14 untitled letters (enforcement actions) on its website that cited 14 different companies for inappropriate sponsored links/search results place on search engines like Google or Yahoo!  I would not ordinarily discuss this issue on GoodReprintPractices.com, but reprint dissemination is only a myopic picture of my [...]]]></description>
		<wfw:commentRss>http://www.goodreprintpractices.com/2009/04/sidetrack-fda-takes-on-internet-promotion/feed/</wfw:commentRss>
		</item>
		<item>
		<title>What is an Acceptable Journal?  Mining the Minutia</title>
		<link>http://www.goodreprintpractices.com/2009/03/what-is-an-acceptable-journal/</link>
		<comments>http://www.goodreprintpractices.com/2009/03/what-is-an-acceptable-journal/#comments</comments>
		<pubDate>Sat, 28 Mar 2009 19:04:18 +0000</pubDate>
		<dc:creator>John</dc:creator>
		
		<category><![CDATA[Featured Articles]]></category>

		<category><![CDATA[21 CFR Part 99]]></category>

		<category><![CDATA[FDAMA 401]]></category>

		<category><![CDATA[Good Reprint Practices]]></category>

		<category><![CDATA[Index Medicus]]></category>

		<category><![CDATA[off label promotion]]></category>

		<category><![CDATA[peer-reviewed reprints]]></category>

		<category><![CDATA[policy adherence]]></category>

		<category><![CDATA[publication practices]]></category>

		<guid isPermaLink="false">http://www.goodreprintpractices.com/?p=205</guid>
		<description><![CDATA[
It’s not lost on me that I’ve been taking a long time to get through my analysis of the Good Reprint Practices guidance.  My first problem is that I’m busy with other things, which in most cases, is a really good thing.  My second problem is that I sometimes go on fantastic voyages into the [...]]]></description>
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		</item>
		<item>
		<title>What is a New Intended Use?  FDA Regulation, Apocalypse Now and Dialectic Physics</title>
		<link>http://www.goodreprintpractices.com/2009/03/what-is-a-new-intended-use-fda-regulation-apocalypse-now-and-dialectic-physics/</link>
		<comments>http://www.goodreprintpractices.com/2009/03/what-is-a-new-intended-use-fda-regulation-apocalypse-now-and-dialectic-physics/#comments</comments>
		<pubDate>Sun, 01 Mar 2009 17:15:37 +0000</pubDate>
		<dc:creator>John</dc:creator>
		
		<category><![CDATA[Featured Articles]]></category>

		<guid isPermaLink="false">http://www.goodreprintpractices.com/?p=181</guid>
		<description><![CDATA[Now it could be that you think I’ve gone mad.  What does Apocalypse Now, the legendary Francis Ford Coppola movie, have to do with Good Reprint Practices?  Does it have something to do with some theme about rebellion, surfing in war zones, madness itself, some parallel to the deterioration of Marlon Brando or to the [...]]]></description>
		<wfw:commentRss>http://www.goodreprintpractices.com/2009/03/what-is-a-new-intended-use-fda-regulation-apocalypse-now-and-dialectic-physics/feed/</wfw:commentRss>
		</item>
		<item>
		<title>Soooo&#8230;What Reprints Fall Under This Guidance?  Do On-label Reprints Apply?&#8230;and other existential questions</title>
		<link>http://www.goodreprintpractices.com/2009/02/soooowhat-reprints-fall-under-this-guidance-do-on-label-reprints-applyand-other-existential-questions/</link>
		<comments>http://www.goodreprintpractices.com/2009/02/soooowhat-reprints-fall-under-this-guidance-do-on-label-reprints-applyand-other-existential-questions/#comments</comments>
		<pubDate>Sat, 07 Feb 2009 15:36:39 +0000</pubDate>
		<dc:creator>John</dc:creator>
		
		<category><![CDATA[Featured Articles]]></category>

		<guid isPermaLink="false">http://www.goodreprintpractices.com/?p=158</guid>
		<description><![CDATA[So&#8230;you may be sitting there trying to put together your thinking about FDA&#8217;s final guidance document.  You may be thinking about whether or not (or how) to put together a company policy or process in light of FDA&#8217;s guidance document.  One day you&#8217;re a college freshman sitting in the Thurston Howell III Memorial Library planning [...]]]></description>
		<wfw:commentRss>http://www.goodreprintpractices.com/2009/02/soooowhat-reprints-fall-under-this-guidance-do-on-label-reprints-applyand-other-existential-questions/feed/</wfw:commentRss>
		</item>
		<item>
		<title>Good Reprint Practices Adds Polls to Survey User Perspectives</title>
		<link>http://www.goodreprintpractices.com/2009/01/good-reprint-practices-adds-polls-to-survey-user-perspectives/</link>
		<comments>http://www.goodreprintpractices.com/2009/01/good-reprint-practices-adds-polls-to-survey-user-perspectives/#comments</comments>
		<pubDate>Wed, 28 Jan 2009 13:45:23 +0000</pubDate>
		<dc:creator>John</dc:creator>
		
		<category><![CDATA[Archives]]></category>

		<guid isPermaLink="false">http://www.goodreprintpractices.com/?p=153</guid>
		<description><![CDATA[Among the more useful things I&#8217;ve always found in my travels as a regulatory and compliance professional are surveys of peers or interested parties related to the things I&#8217;m interested in.  GoodReprintPractices.com has added a polling function and I ask all relevant users to participate as they visit the site.  Hopefully, this will help me [...]]]></description>
		<wfw:commentRss>http://www.goodreprintpractices.com/2009/01/good-reprint-practices-adds-polls-to-survey-user-perspectives/feed/</wfw:commentRss>
		</item>
		<item>
		<title>John&#8217;s Struggles With Introductory Sections of FDA&#8217;s Guidance Document</title>
		<link>http://www.goodreprintpractices.com/2009/01/johns-struggles-with-introductory-sections-fdas-guidance-document/</link>
		<comments>http://www.goodreprintpractices.com/2009/01/johns-struggles-with-introductory-sections-fdas-guidance-document/#comments</comments>
		<pubDate>Sun, 25 Jan 2009 16:16:24 +0000</pubDate>
		<dc:creator>John</dc:creator>
		
		<category><![CDATA[Featured Articles]]></category>

		<category><![CDATA[21 CFR Part 99]]></category>

		<category><![CDATA[FDA regulation of journal articles]]></category>

		<category><![CDATA[FDAMA 401]]></category>

		<category><![CDATA[Good Reprint Practices]]></category>

		<category><![CDATA[off label promotion]]></category>

		<category><![CDATA[peer-reviewed reprints]]></category>

		<category><![CDATA[Reprint dissemination]]></category>

		<category><![CDATA[Washington Legal Foundation]]></category>

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

		<guid isPermaLink="false">http://www.goodreprintpractices.com/?p=120</guid>
		<description><![CDATA[The introductory text of FDA&#8217;s Final Guidance Document (see image) states that the Guidance represents FDA&#8217;s current thinking on how drug and device manufacturers may disseminate reprints related to &#8220;off-label&#8221; or investigational uses of regulated products.  Importantly, (and we&#8217;ll get into this more in subsequent posts) it does not allow for companies to promote unapproved or [...]]]></description>
		<wfw:commentRss>http://www.goodreprintpractices.com/2009/01/johns-struggles-with-introductory-sections-fdas-guidance-document/feed/</wfw:commentRss>
		</item>
		<item>
		<title>While you eagerly await our detailed analyses of GRP Guidance document&#8230;</title>
		<link>http://www.goodreprintpractices.com/2009/01/while-you-eagerly-await-our-detailed-analyses-of-grp-guidance-document/</link>
		<comments>http://www.goodreprintpractices.com/2009/01/while-you-eagerly-await-our-detailed-analyses-of-grp-guidance-document/#comments</comments>
		<pubDate>Fri, 23 Jan 2009 18:31:54 +0000</pubDate>
		<dc:creator>John</dc:creator>
		
		<category><![CDATA[Featured Articles]]></category>

		<guid isPermaLink="false">http://www.goodreprintpractices.com/?p=83</guid>
		<description><![CDATA[We&#8217;ve announced in our previous posts that GoodReprintPractices.com will be doing some deep dive perspective-giving and analyses.  While your eagerly awaiting this wisdom, other really smart people have done their analysis and here are some places to go:
The FDA Law Blog 
The Life Sciences Legal Update 
Hat tips to the Drug and Device Law blog for pointing [...]]]></description>
		<wfw:commentRss>http://www.goodreprintpractices.com/2009/01/while-you-eagerly-await-our-detailed-analyses-of-grp-guidance-document/feed/</wfw:commentRss>
		</item>
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		<title>Diversion of Sorts:  John discusses social media issues with Pharma Marketing Blog</title>
		<link>http://www.goodreprintpractices.com/2009/01/diversion-of-sorts-john-discusses-social-media-issues-with-pharma-marketing-blog/</link>
		<comments>http://www.goodreprintpractices.com/2009/01/diversion-of-sorts-john-discusses-social-media-issues-with-pharma-marketing-blog/#comments</comments>
		<pubDate>Fri, 23 Jan 2009 04:05:36 +0000</pubDate>
		<dc:creator>John</dc:creator>
		
		<category><![CDATA[Archives]]></category>

		<guid isPermaLink="false">http://www.goodreprintpractices.com/?p=79</guid>
		<description><![CDATA[I took it upon myself to mix it up with John Mack at the Pharma Marketing Blogs. I got the &#8220;John Mack treatment.&#8221; I like John&#8217;s attitude and attentiveness to the pharma world. My diatribes and appearances are here and here. Read the comments.  Nothing here about GoodReprintPractices.com.  Just some regulatory discussion.
JM (John Murray not [...]]]></description>
		<wfw:commentRss>http://www.goodreprintpractices.com/2009/01/diversion-of-sorts-john-discusses-social-media-issues-with-pharma-marketing-blog/feed/</wfw:commentRss>
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