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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2007-11-23/</link>
    <description>Daily Publications of Meetings and Rules Changes for the Federal Government</description>
    <pubDate>Sat, Nov 22 2008 11:00:00 GMT</pubDate>
    <lastBuildDate>Sat, Nov 22 2008 11:00:00 GMT</lastBuildDate>
    <webMaster>info@thefederalregister.com</webMaster>
    <item>
  <title><![CDATA[  New Animal Drugs For Use in Animal Feeds; Ractopamine ]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-23-E7-22882</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Elanco Animal Health. The supplemental NADA 
provides for an increased level of monensin in twoway combination Type 
B and Type C medicated feeds containing ractopamine hydrochloride and 
monensin for cattle fed in confinement for slaughter.
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  <guid>http://thefederalregister.com/d.p/2007-11-23-E7-22882</guid>
  <pubDate>Fri, Nov 23 2007 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Memorandum of Understanding Between the Food and Drug  Administration and Duke University]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-23-07-5793</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between FDA and Duke University. 
The purpose of this MOU is to establish the terms of collaboration 
between FDA and Duke, beginning with an initiative to strengthen Human 
Subjects Protection by reexamining and modernizing the conduct of 
clinical trials to ensure that design, execution, and analysis are of 
optimal quality. To this end, Duke will be the convener of a Public 
Private Partnership, to which FDA will be a founding partner, to 
systematically modernize the clinical trial process.
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  <guid>http://thefederalregister.com/d.p/2007-11-23-07-5793</guid>
  <pubDate>Fri, Nov 23 2007 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Compliance Policy Guide; Radiofrequency Identification  Feasibility Studies and Pilot Programs for Drugs; Notice to]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-23-E7-22818</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is extending the 
expiration date of the compliance policy guide (CPG) entitled ``Sec. 
400.210Radiofrequency Identification (RFID) Feasibility Studies and 
Pilot Programs for Drugs'' to December 31, 2008.
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  <guid>http://thefederalregister.com/d.p/2007-11-23-E7-22818</guid>
  <pubDate>Fri, Nov 23 2007 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Draft Guidance for Industry on Smallpox (Variola) Infection:  Developing Drugs for Treatment or Prevention;]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-23-E7-22884</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Smallpox 
(Variola) Infection: Developing Drugs for Treatment or Prevention.'' In 
this draft guidance, FDA provides recommendations on the development of 
drugs to be used to treat or prevent smallpox (variola) infection. This 
guidance is intended to help sponsors plan and design appropriate 
studies during the development of these drugs.
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  <guid>http://thefederalregister.com/d.p/2007-11-23-E7-22884</guid>
  <pubDate>Fri, Nov 23 2007 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  International Cooperation on Harmonisation of Technical  Requirements for Registration of Veterinary Medicinal]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-23-E7-22900</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry (<greeki>73) entitled 
``Stability Testing of New Veterinary Drug Substances and Medicinal 
Products (Revision) VICH GL3(R).'' This revised guidance has been 
developed for veterinary use by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). This revised document is intended to provide 
guidance regarding the development of stability testing data for new 
animal drug applications (referred to as registration applications in 
the guidance) submitted to the European Union (EU), Japan, and United 
States.
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  <guid>http://thefederalregister.com/d.p/2007-11-23-E7-22900</guid>
  <pubDate>Fri, Nov 23 2007 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  International Cooperation on Harmonisation of Technical  Requirements for Registration of Veterinary Medicinal]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-23-E7-22901</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry (<greeki>93) entitled 
``Impurities in New Veterinary Medicinal Products (Revision)'' VICH 
GL11(R). This revised guidance has been developed for veterinary use by 
the International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH). 
This revised document is intended to assist in developing registration 
applications for approval of veterinary medicinal products submitted to 
the European Union, Japan, and the United States. The revised guidance 
addresses only those impurities in new veterinary medicinal drug 
products classified as degradation products.
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  <guid>http://thefederalregister.com/d.p/2007-11-23-E7-22901</guid>
  <pubDate>Fri, Nov 23 2007 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  International Cooperation on Harmonisation of Technical  Requirements for Registration of Veterinary Medicinal]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-23-E7-22902</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry (<greeki>92) entitled 
``Impurities in New Veterinary Drug Substances (Revision)'' VICH 
GL10(R). This revised guidance has been developed for veterinary use by 
the International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH). 
The revised document is intended to provide guidance for registration 
applicants on the content and qualification of impurities in new 
veterinary drug substances produced by chemical syntheses and not 
previously registered in a country, region, or member state.
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  <guid>http://thefederalregister.com/d.p/2007-11-23-E7-22902</guid>
  <pubDate>Fri, Nov 23 2007 11:00:00 GMT</pubDate>
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