2006N-0464
  

  
 Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC6
  



  

  
Submitter : 
  

  
Dr. S. Albert Edwards
  

  
Date & Time: 
  

  
12/08/2006 09:12:21
  



  

  
Organization : 
  

  
TAP Pharmaceutical Products Inc
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I would like to make a presentation of approximately 30 minutes in length on this topic at the public meeting scheduled for December 18, 2006. My summary follows:  



We, the FDA and industry, must work together very closely and understnad each other's systems and process to build and sustain a viable and durable electronic submission paradigm.  We must carefully select and closely supervise any third parties.  We must learn how to efficiently handle and access repetitive submission information, e.g., Investigator 1572 and CV information.  We must find common ground to move forward in making electronic submissions a requirement.  The common ground must include a Master Plan.  The Master Plan must include a life cycle development process as well as a 'Plan B' disaster recovery plan.  Finally, the electronic submission meta-data and infrastructure must equal the importance assigned to the submission content if we are to collectively progress from electronic submissions attaining 3-5% of all FDA submissions to a 95%+ level of submission being electronic.