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    <title>Recent Food &amp; Drug Regulation Newsbriefs on Thompson.com</title>
    <link>http://www.thompson.com/public/library.jsp?cat=FOODDRUG</link>
    <description>The Food and Drug Regulation Library provides complete, reliable information on: FDA regulation, FDA compliance and enforcement, FDA and Federal Trade Commission (FTC) advertising policies, how and why FDA conducts inspections, responding to 483s and warning letters, medical device regulation, food labeling, clinical trials of new drugs, devices, and biologics dietary supplements, pharmaceutical, food and drug law, genetically modified food labeling, nutrition labeling, nutrient content and health claims, U.S. Department of Agriculture labeling rules, country-of-origin labeling, Food and Drug Administration (FDA), FDA Modernization Act (FDAMA), Prescription Drug User Fee Act (PDUFA), biotechnology regulations, in-vitro diagnostic device (IVD) regulation, Federal Food Drug and Cosmetic Act, and good manufacturing practices (GMPs).</description>
    <language>en-us</language>
    <copyright>Copyright 2010Thompson Publishing Group. All Rights Reserved.</copyright>
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   <item>
  	<title><![CDATA[Allergan To Pay $600 Million To Resolve Off-label Marketing Allegations, Agrees To Drop First Amendment Suit]]></title> 
<link>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=3069</link> 
<description><![CDATA[
	Allergan Inc. agreed to pay $375 million and plead guilty to a misdemeanor charge of misbranding as part of a settlement with the Department of Justice resolving allegations that the company...]]></description>
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   <item>
  	<title><![CDATA[FDA Becoming More Rigorous in Review, Acceptance of Non-inferiority Trials: GAO]]></title> 
<link>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=3068</link> 
<description><![CDATA[The FDA has become more rigorous in its review and acceptance of non-inferiority trials in new drug application (NDA) approvals, the Government Accountability Office (GAO) concluded.
The &ldquo;FDA...]]></description>
<guid>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=3068</guid>
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   <item>
  	<title><![CDATA[Former Colorado Device Company Executives Indicted]]></title> 
<link>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=3066</link> 
<description><![CDATA[
	Federal prosecutors Aug. 30 announced the indictment of three former executives of Colorado Springs, Colo.-based Spectranetics Corp. on charges of conspiracy, false statements, importation...]]></description>
<guid>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=3066</guid>
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   <item>
  	<title><![CDATA[Major Changes Proposed for 510(k) Program]]></title> 
<link>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=3011</link> 
<description><![CDATA[
	The Center for Devices and Radiological Health (CDRH) should establish a subset of class II devices called class IIb, a preliminary report from the Center&rsquo;s 510(k) Working Group...]]></description>
<guid>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=3011</guid>
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   <item>
  	<title><![CDATA[FDA, NIH Should Examine Old Trials To Understand Missing Data Problems]]></title> 
<link>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=2980</link> 
<description><![CDATA[
	A National Research Council panel urged the FDA and the National Institutes of Health to &ldquo;make use of their extensive clinical trial database to carry out a program of research to identify...]]></description>
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   <item>
  	<title><![CDATA[PhRMA Taps Business Roundtable CEO John Castellani To Succeed Tauzin]]></title> 
<link>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=2963</link> 
<description><![CDATA[
	The prominent trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has selected a new CEO, drawing from another trade organization.

	John Castellani, who currently heads...]]></description>
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  	<title><![CDATA[FDA To Conduct Inspections Focusing on Part 11]]></title> 
<link>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=2958</link> 
<description><![CDATA[
	The FDA announced July 8 that it will &ldquo;soon&rdquo; begin conducting a series of &ldquo;focused&rdquo; inspections to evaluate industry compliance with and understanding of 21 C.F.R. Part 11,...]]></description>
<guid>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=2958</guid>
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   <item>
  	<title><![CDATA[FDA Adds Info on International Inspections to Its Guidance]]></title> 
<link>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=2942</link> 
<description><![CDATA[
	The FDA&rsquo;s revised information sheet&nbsp;on clinical investigator inspections includes a new section on international inspections.

	The guidance noted that &ldquo;although sponsors of...]]></description>
<guid>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=2942</guid>
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   <item>
  	<title><![CDATA[AAHRPP Survey Finds HRPP Workload Increasing]]></title> 
<link>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=2937</link> 
<description><![CDATA[
	A survey of 196 research organizations by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP) found that 87.6 percent reported an increase in the workload of...]]></description>
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  	<title><![CDATA[FDA Needs To Improve Its Oversight of Foreign Trials: OIG]]></title> 
<link>http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&amp;id=2921</link> 
<description><![CDATA[	The Department of Health and Human Services Office of Inspector General (OIG) said the FDA needs to &ldquo;improve its system for overseeing foreign clinical trials&rdquo; in a report&nbsp;released...]]></description>
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