2006N-0464
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC29
  



  

  
Submitter : 
  

  
Dr. John Aitken
  

  
Date & Time: 
  

  
01/19/2007 10:01:15
  



  

  
Organization : 
  

  
Dr. John Aitken
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I work for a medium-sized pharmaceutical company that has been submitting INDs electronically as eCTD to CDER and CBER since early 2005. We made the decision to do this because we already preparing all of our documents electronically. The company was large enough to justify making this change financially, plus we had electronic document management and publishing systems in place, existing publishing staff, internal IT support, and enough regular submissions to keep publishing staff fully occupied.



For many small companies this is not the case. They cannot justify the cost of implementing the electronic systems needed to produce electronic documents and prepare eCTD submissions, nor to hire and train the staff to use and support those systems, when they only have one or two INDs. An alternative for small companies would be to outsource electronic submissions to contract research organizations. This means that small companies would be totally dependent on CROs to create and maintain their INDs, at much greater cost than manually preparing IND submissions as paper. In addition, many small companies have no intention of developing their drugs past phase 1 or 2, and plan to license their drugs to big pharma. They see no benefit to submitting INDs electronically if the licensor and not the small company will be compiling the eNDA or eBLA.



FDAs approach to mandating electronic submissions might want to consider requiring, for example, all NDAs and BLAs as eCTD, but initially only INDs that have reached reach a certain phase of development. This will reduce the burden on small companies with early INDs. However, any company that can afford a phase 3 drug development program can afford to submit eCTDs. For many, the main reason they do not do so is to avoid 21 CFR part 11.