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	<title>Weinberg on FDA</title>
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		<title>Please Join us for our Next Webinar: Evaluating Product Risk in a Rapidly Changing Environment</title>
		<link>http://www.weinbergonfda.com/index.php/2012/07/evaluating-product-risk-in-a-rapidly-changing-environment/</link>
		<comments>http://www.weinbergonfda.com/index.php/2012/07/evaluating-product-risk-in-a-rapidly-changing-environment/#comments</comments>
		<pubDate>Tue, 10 Jul 2012 14:29:54 +0000</pubDate>
		<dc:creator>claire.robertson</dc:creator>
				<category><![CDATA[Regulations]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Webinars]]></category>
		<category><![CDATA[Weinberg Group Announcements]]></category>
		<category><![CDATA[Product Risk]]></category>
		<category><![CDATA[regulations]]></category>

		<guid isPermaLink="false">http://www.weinbergonfda.com/?p=754</guid>
		<description><![CDATA[“Evaluating Product Risk in a Rapidly Changing Environment” A Webinar Presented by The Weinberg Group Wednesday, July 25, 2012 12 p.m. (EDT) &#124; 9 a.m. (PDT) &#124; 5 p.m. (GMT) Online Registration With the dramatic increase in legislative and regulatory focus on consumer health and safety, and employee health and safety, companies&#8217; products are more [...]]]></description>
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		<title>Latest Drug Approval Via the Animal Rule: The Black Death</title>
		<link>http://www.weinbergonfda.com/index.php/2012/07/animal-rule/</link>
		<comments>http://www.weinbergonfda.com/index.php/2012/07/animal-rule/#comments</comments>
		<pubDate>Mon, 02 Jul 2012 19:07:59 +0000</pubDate>
		<dc:creator>Bob Roth</dc:creator>
				<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Levaquin]]></category>
		<category><![CDATA[The Animal Rule]]></category>

		<guid isPermaLink="false">http://www.weinbergonfda.com/?p=750</guid>
		<description><![CDATA[To clarify the somewhat misleading title, the latest drug approval using FDA’s Animal Rule is to expand the approved indications for Levaquin to the treatment and prevention of plague due to pulmonic or systemic infection with Yersinia pestis. Although other antibiotics are indicated as treatment for Y. pestis infection, the novel component of the Levaquin [...]]]></description>
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		<title>Biologics, Biosimilars and Looking Into the Abyss</title>
		<link>http://www.weinbergonfda.com/index.php/2012/06/patent-cliff/</link>
		<comments>http://www.weinbergonfda.com/index.php/2012/06/patent-cliff/#comments</comments>
		<pubDate>Tue, 19 Jun 2012 19:54:04 +0000</pubDate>
		<dc:creator>Joel Falk</dc:creator>
				<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[Drug Formulation]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA Regulatory Process]]></category>
		<category><![CDATA[Regulations]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Biologics Price Competition and Innovation Act of 2009]]></category>
		<category><![CDATA[Biosimiliars]]></category>
		<category><![CDATA[patents]]></category>

		<guid isPermaLink="false">http://www.weinbergonfda.com/?p=743</guid>
		<description><![CDATA[The double-edged aspect, and certainly the more negative side, of being protected by a patent comes at the end of that protection. Patent cliffs have become part of the pharmaceutical industry’s vernacular in that a company’s revenues can appear to be falling off a cliff when a product comes off patent; when the patent term [...]]]></description>
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		<title>GRAS – One of FDA’s Most Widely Misunderstood Acronyms (Part 3)</title>
		<link>http://www.weinbergonfda.com/index.php/2012/06/generally-recognized-as-safe-part-3/</link>
		<comments>http://www.weinbergonfda.com/index.php/2012/06/generally-recognized-as-safe-part-3/#comments</comments>
		<pubDate>Mon, 11 Jun 2012 18:30:03 +0000</pubDate>
		<dc:creator>Carrie Rabe</dc:creator>
				<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[Drug Formulation]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA Guidance]]></category>
		<category><![CDATA[Regulations]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[FDA regulatory process]]></category>
		<category><![CDATA[GRAS]]></category>
		<category><![CDATA[regulations]]></category>

		<guid isPermaLink="false">http://www.weinbergonfda.com/?p=736</guid>
		<description><![CDATA[The third installment of this series addresses the misconception that in order to be designated “GRAS,” a substance must have been extensively tested and definitively proven to be safe. Many substances have been designated GRAS for their intended use(s) based solely on knowledge of their common use in foods prior to 1958. The presumption of [...]]]></description>
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		<title>Please Join Us For Our Next Webinar: Ensuring Successful FDA Meetings</title>
		<link>http://www.weinbergonfda.com/index.php/2012/06/please-join-us-for-our-next-webinar-ensuring-successful-fda-meetings/</link>
		<comments>http://www.weinbergonfda.com/index.php/2012/06/please-join-us-for-our-next-webinar-ensuring-successful-fda-meetings/#comments</comments>
		<pubDate>Mon, 04 Jun 2012 14:52:44 +0000</pubDate>
		<dc:creator>claire.robertson</dc:creator>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Webinars]]></category>
		<category><![CDATA[Weinberg Group Announcements]]></category>
		<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA regulatory process]]></category>
		<category><![CDATA[regulations]]></category>
		<category><![CDATA[webinar]]></category>

		<guid isPermaLink="false">http://www.weinbergonfda.com/?p=732</guid>
		<description><![CDATA[&#8220;Ensuring Successful FDA Meetings&#8221; Wednesday, June 20, 2012 12 p.m. (EDT) &#124; 9 a.m. (PDT) &#124; 5 p.m. (GMT) Online Registration FDA meetings, regardless of when they occur &#8212; from pre-IND, to End-of-Phase 2, to pre-NDA meetings &#8212; can make or break your chances of bringing your product to final approval. Ensuring successful meetings is [...]]]></description>
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		<title>Latest Guidances on “Nano” Product Development and Regulation</title>
		<link>http://www.weinbergonfda.com/index.php/2012/05/nanomaterials/</link>
		<comments>http://www.weinbergonfda.com/index.php/2012/05/nanomaterials/#comments</comments>
		<pubDate>Tue, 29 May 2012 15:16:22 +0000</pubDate>
		<dc:creator>Bob Roth</dc:creator>
				<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[Drug Formulation]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA Guidance]]></category>
		<category><![CDATA[Regulations]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[draft guidance]]></category>
		<category><![CDATA[Nanomaterials]]></category>
		<category><![CDATA[regulations]]></category>

		<guid isPermaLink="false">http://www.weinbergonfda.com/?p=725</guid>
		<description><![CDATA[Two new draft guidances related to the use of nano materials in FDA-regulated products have been issued for public consideration and comments. These draft guidances, Safety of Nanomaterials in Cosmetic Products, and Assessing the Effects of Significant Manufacturing Process Changes, follow last year’s general guidance on when nanotechnology applies to FDA-regulated products. These draft guidances [...]]]></description>
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		<slash:comments>0</slash:comments>
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		<item>
		<title>Extended Review Timeline for Certain Applications under Proposed PDUFA V</title>
		<link>http://www.weinbergonfda.com/index.php/2012/05/pdufa-v/</link>
		<comments>http://www.weinbergonfda.com/index.php/2012/05/pdufa-v/#comments</comments>
		<pubDate>Mon, 21 May 2012 15:00:37 +0000</pubDate>
		<dc:creator>Marla Scarola</dc:creator>
				<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[PDUFA]]></category>
		<category><![CDATA[Regulations]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[GDUFA]]></category>
		<category><![CDATA[regulations]]></category>

		<guid isPermaLink="false">http://www.weinbergonfda.com/?p=718</guid>
		<description><![CDATA[The Prescription Drug User Fee Act (PDUFA) is due to be reauthorized by the end of September this year. Along with the usual increases in fees, the latest version of the act (PDUFA V) includes some new initiatives. One of these is a program for enhanced review transparency and communication which will apply to all [...]]]></description>
		<wfw:commentRss>http://www.weinbergonfda.com/index.php/2012/05/pdufa-v/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>GRAS – One of FDA’s Most Widely Misunderstood Acronyms (Part 2)</title>
		<link>http://www.weinbergonfda.com/index.php/2012/05/gras-part-2/</link>
		<comments>http://www.weinbergonfda.com/index.php/2012/05/gras-part-2/#comments</comments>
		<pubDate>Mon, 14 May 2012 15:03:03 +0000</pubDate>
		<dc:creator>Carrie Rabe</dc:creator>
				<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[Drug Formulation]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA Patient Safety]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[GRAS]]></category>

		<guid isPermaLink="false">http://www.weinbergonfda.com/?p=712</guid>
		<description><![CDATA[Another of the widely held misconceptions about GRAS status is that it means that an ingredient is considered safe by the FDA, irrespective of how much is used and for what purpose. This interpretation is, however, quite different than what is stated in Section 201(s) of the Federal Food Drug &#038; Cosmetic Act wherein GRAS [...]]]></description>
		<wfw:commentRss>http://www.weinbergonfda.com/index.php/2012/05/gras-part-2/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
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		<item>
		<title>Label Changes Related to the QTc Interval</title>
		<link>http://www.weinbergonfda.com/index.php/2012/05/label-changes-related-to-the-qtc-interval/</link>
		<comments>http://www.weinbergonfda.com/index.php/2012/05/label-changes-related-to-the-qtc-interval/#comments</comments>
		<pubDate>Mon, 07 May 2012 15:41:38 +0000</pubDate>
		<dc:creator>Bob Roth</dc:creator>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA Patient Safety]]></category>
		<category><![CDATA[Label Changes]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[drug labeling]]></category>
		<category><![CDATA[FDA patient safety]]></category>
		<category><![CDATA[regulations]]></category>

		<guid isPermaLink="false">http://www.weinbergonfda.com/?p=704</guid>
		<description><![CDATA[In a recent FDA Drug Safety Communication, the Agency announced that the Celexa (citalopram hydrobromide) label now has revised dosing recommendations based on evaluations of post-marketing reports related to QTc prolongation and thorough QTC studies.  The label reasonably stresses the importance of routine ECG monitoring and provides an upper level of prolongation that would necessitate [...]]]></description>
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		<slash:comments>0</slash:comments>
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		<title>FDA Study Finds Lower Risk of Lung Cancer Among Menthol Smokers</title>
		<link>http://www.weinbergonfda.com/index.php/2012/04/tpsac-menthol-public-health/</link>
		<comments>http://www.weinbergonfda.com/index.php/2012/04/tpsac-menthol-public-health/#comments</comments>
		<pubDate>Mon, 30 Apr 2012 14:35:43 +0000</pubDate>
		<dc:creator>Marla Scarola</dc:creator>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[Regulations]]></category>
		<category><![CDATA[Tobacco]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[menthol]]></category>
		<category><![CDATA[TPSAC]]></category>

		<guid isPermaLink="false">http://www.weinbergonfda.com/?p=690</guid>
		<description><![CDATA[In March 2011, the Tobacco Products Scientific Advisory Committee released a report on the impact of menthol on public health.  Based on the committee’s review of all available evidence, they recommended the ban of menthol.  Following the release of TPSAC’s report, the FDA began a thorough review of their findings and also considered a report [...]]]></description>
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