2004N-0181 - Critical Path Initiative; Establishment of Docket
  


  

  


  

  
FDA Comment Number : 
  

  
EC18
  



  

  

  



  

  
Submitter : 
  

  
Dr. Jeffrey Lerner
  

  
Date & Time: 
  

  
08/02/2004 06:08:01
  



  

  
Organization : 
  

  
ECRI
  



  

  
Other Organization
  


  

  
Category : 
  



  

  
Issue Areas/Comments 
  


  

  


  

  
Comment Issues
  


  

  



  

  
 1. Hurdle Identification. Please describe the product development issue, the nature of the evaluation tool that is out-of-date or absent, how this problem hinders product development, and how a solution would improve the product development process. 

  


  

  


  

  



  

  
See general comment in last field.
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 ECRI is planning to provide detailed comments shortly. We believe this is an important initiative. Our comments will support continuing and enhanced scientific evaluation of products as a key to improved process.