2006N-0062
  

  
Expanded Access to Investigational Drugs for Treatment Use
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC33
  



  

  
Submitter : 
  

  
Mr. Robert Erwin
  

  
Date & Time: 
  

  
03/13/2007 06:03:19
  



  

  
Organization : 
  

  
Marti Nelson Cancer Foundation
  



  

  
Category : 
  

  
Consumer Group
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 The Marti Nelson Cancer Foundation supports the FDA's proposed approach to expanded access to investigational drugs.  These guidelines clarify the circumstances under which such access is appropriate.  They also provide a mechanism to remove or reduce financial obstacles to providing access, but with important refinements and clarification of definitions to prevent direct or indirect profiting from unapproved therapeutics.