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 : 
  

  
EC4141
  



  

  
Submitter : 
  

  
Mr. DONALD  KALCIK
  

  
Date & Time: 
  

  
12/22/2006 11:12:43
  



  

  
Organization : 
  

  
Mr. DONALD  KALCIK
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I want to strongly urge revision of the guidelines to explicitly prohibit the use of tissue from directly aborted fetuses and destroyed embryos in the future, in the development of vaccines to be approved by th FDA.  I also urge the FDA to encourge and approve the development of cell lines not derived from tissue taken from directly aborted fetuses and the approval of the importation of save vaccines which have been manufactured without using cell lines from aborted fetuses or destroyed embroyos.