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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2006-12-14/</link>
    <description>Daily Publications of Meetings and Rules Changes for the Federal Government</description>
    <pubDate>Sun, Nov 23 2008 11:00:00 GMT</pubDate>
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  <title><![CDATA[  Charging for Investigational Drugs ]]></title>
  <link>http://thefederalregister.com/d.p/2006-12-14-06-9685</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is proposing to amend 
its investigational new drug application (IND) regulation concerning 
charging patients for investigational new drugs. FDA is proposing to 
revise the current charging regulation to clarify the circumstances in 
which charging for an investigational drug in a clinical trial is 
appropriate, to set forth criteria for charging for an investigational 
drug for the different types of expanded access for treatment use 
described in the agency's proposed rule on expanded access for 
treatment use of investigational drugs published elsewhere in this 
issue of the Federal Register, and to clarify what costs can be 
recovered for an investigational drug. The proposed rule is intended to 
permit charging for a broader range of investigational and expanded 
access uses than is explicitly permitted in current regulations.
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  <guid>http://thefederalregister.com/d.p/2006-12-14-06-9685</guid>
  <pubDate>Thu, Dec 14 2006 11:00:00 GMT</pubDate>
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  <title><![CDATA[  Expanded Access to Investigational Drugs for Treatment Use]]></title>
  <link>http://thefederalregister.com/d.p/2006-12-14-06-9684</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is proposing to amend 
its regulations on access to investigational new drugs for the 
treatment of patients. The proposed rule would clarify existing 
regulations and add new types of expanded access for treatment use. 
Under the proposal, expanded access to investigational drugs for 
treatment use would be available to individual patients, including in 
emergencies; intermediatesize patient populations; and larger 
populations under a treatment protocol or treatment investigational new 
drug application (IND). The proposed rule is intended to improve access 
to investigational drugs for patients with serious or immediately life
threatening diseases or conditions, who lack other therapeutic options 
and who may benefit from such therapies.
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  <guid>http://thefederalregister.com/d.p/2006-12-14-06-9684</guid>
  <pubDate>Thu, Dec 14 2006 11:00:00 GMT</pubDate>
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