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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2007-12-17/</link>
    <description>Daily Publications of Meetings and Rules Changes for the Federal Government</description>
    <pubDate>Thu, Aug 21 2008 11:00:00 GMT</pubDate>
    <lastBuildDate>Thu, Aug 21 2008 11:00:00 GMT</lastBuildDate>
    <webMaster>info@thefederalregister.com</webMaster>
    <item>
  <title><![CDATA[  International Conference on Harmonisation; Draft Guidance on Q4B  Evaluation and Recommendation of Pharmacopoeial]]></title>
  <link>http://thefederalregister.com/d.p/2007-12-17-E7-24431</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Q4B Evaluation and 
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; 
Annex 3: Test for Particulate Contamination: Subvisible Particles 
General Chapter.'' The draft guidance was prepared under the auspices 
of the International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
The draft guidance provides the results of the ICH Q4B evaluation of 
the Test for Particulate Contamination: Subvisible Particles General 
Chapter harmonized text from each of the three pharmacopoeias (United 
States, European, and Japanese) represented by the Pharmacopoeial 
Discussion Group (PDG). The draft guidance conveys recognition of the 
three pharmacopoeial methods by the three ICH regulatory regions and 
provides specific information regarding the recognition. The draft 
guidance is intended to recognize the interchangeability between the 
loca<script type="text/javascript">
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  <guid>http://thefederalregister.com/d.p/2007-12-17-E7-24431</guid>
  <pubDate>Mon, Dec 17 2007 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  International Conference on Harmonisation; Draft Guidance on Q4B  Evaluation and Recommendation of Pharmacopoeial]]></title>
  <link>http://thefederalregister.com/d.p/2007-12-17-E7-24434</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Q4B Evaluation and 
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; 
Annex 2: Test for Extractable Volume of Parenteral Preparations General 
Chapter.'' The draft guidance was prepared under the auspices of the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). The draft guidance 
provides the results of the ICH Q4B evaluation of the Test for 
Extractable Volume of Parenteral Preparations General Chapter 
harmonized text from each of the three pharmacopoeias (United States, 
European, and Japanese) represented by the Pharmacopoeial Discussion 
Group (PDG). The draft guidance conveys recognition of the three 
pharmacopoeial methods by the three ICH regulatory regions and provides 
specific information regarding the recognition. The draft guidance is 
intended to recognize the interchangeability between the local reg<script type="text/javascript">
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]]></description>
  <guid>http://thefederalregister.com/d.p/2007-12-17-E7-24434</guid>
  <pubDate>Mon, Dec 17 2007 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Guidance for Industry and Food and Drug Administration Review  Staff: Collection of Platelets by Automated Methods;]]></title>
  <link>http://thefederalregister.com/d.p/2007-12-17-E7-24385</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry and FDA 
Review Staff: Collection of Platelets by Automated Methods,'' dated 
December 2007. The guidance document provides to blood establishments 
and FDA staff revised recommendations for the collection of Platelets 
by automated methods (plateletpheresis). The guidance is intended to 
help blood establishments ensure donor safety and the safety, purity, 
and potency of Platelets collected by an automated blood cell separator 
device. For the purpose of this document, Platelets collected by 
automated methods will be referred to by the product name ``Platelets, 
Pheresis.'' The document contains recommendations for appropriate 
criteria for a biologics license application or supplement for 
manufacturing Platelets, Pheresis. The guidance announced in this 
notice finalizes the draft guidance of the same title dated September 
2005, and supersedes the guidance entitled ``Revised Guideline f<script type="text/javascript">
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  <guid>http://thefederalregister.com/d.p/2007-12-17-E7-24385</guid>
  <pubDate>Mon, Dec 17 2007 11:00:00 GMT</pubDate>
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