2006D-0044
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC9
  



  

  
Submitter : 
  

  
Dr. David  Cella
  

  
Date & Time: 
  

  
04/14/2006 12:04:31
  



  

  
Organization : 
  

  
FACIT.org
  



  

  
Category : 
  

  
Academia
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 This public response forum is a useful venue to clear up some apparent misperceptions about the FACT and FACIT measures with regard to the FDA PRO draft guidance. Thank you for this opportunity.



The draft guidance articulates several opinions that relate to FACIT questionnaires and bear clarification. We hope the reader of the attached comment will disseminate it through the agency to avoid future misunderstanding. 



The FACT/FACIT stand up very well in terms of compliance with guidance, and yet there are focal concerns raised by the guidance that impede our ability to use any number of instruments (virtually all instruments, FACT included), which may be a disservice to the patients, and the general public, we are here to serve.





PLEASE SEE THE ATTACHED DETAILED RESPONSE.









  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
2006D-0044-EC9-Attach-1.DOC