2006D-0383
  

  
 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases

  


  

  

  


  

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2719
  



  

  
Submitter : 
  

  
Ms. Molly Leping
  

  
Date & Time: 
  

  
12/07/2006 11:12:32
  



  

  
Organization : 
  

  
Ms. Molly Leping
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Revise your policy and DO NOT use fetal cell lines in vaccinations. Pharmaceutal companies need to be held accountable to ethical standards similiar to NIH. There are many unknown risks by introducing foreign genetic material into a vaccination that may cause a pandemic.