2005N-0403
  

  
 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs

  


  

  

  


  

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC3
  



  

  
Submitter : 
  

  
Ms. C Richesson
  

  
Date & Time: 
  

  
11/27/2006 10:11:57
  



  

  
Organization : 
  

  
Ben Venue Laboratories, Inc.
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 We at Ben Venue Laboratories have a couple of main concerns about the FDA proposal to take over the assignment of NDC numbers:



1)Timeliness: How long would it take FDA to assign an NDC number? Here at Ben Venue, the NDC number is the driving force behind new product development. Everything from the master production record to the packout assignment is controlled by the NDC number. We are concerned about delays in the assignment of the NDC number and the impact delays would have on the development and eventual marketing of new products.


2)Confidentiality: If FDA controls the assignment of NDC numbers, will the information provided in order to receive an NDC number remain restricted? Currently at Ben Venue, NDC numbers are assigned in-house, which maintains their confidentiality and safeguards competition among manufacturers. If this information were to become public and future development plans made known, it may tip the market in favor of one manufacturer over another.



For these reasons and others, we suggest FDA devotes it resources to enhancing education and enforcement of the current guidelines rather than spending the considerable time and effort on creating and regulating a completely new system.