2006D-0331
  

  
  Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC45
  



  

  
Submitter : 
  

  
Mr. Gary Cooper
  

  
Date & Time: 
  

  
10/27/2006 09:10:32
  



  

  
Organization : 
  

  
AstraZeneca LP
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
See Attachment
  


  

  



  

  
2006D-0331-EC45-Attach-1.PDF