2006D-0044
  

  
 Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Dr. Christina Meyers
  

  
Date & Time: 
  

  
04/07/2006 05:04:42
  



  

  
Organization : 
  

  
M. D. Anderson Cancer Center
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Questions regarding cognitive function (e.g., self report of attention, memory problems, etc.) cannot be used as proxy for tested cognitive function. If cognitive function is an issue for a given PRO, it must be objectively assessed.