2003D-0206 - Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products--Submitting New Drug Application; Availability

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  

  



  

  
Submitter : 
  

  
Dr. Drucy Borowitz
  

  
Date & Time: 
  

  
06/10/2004 05:06:15
  



  

  
Organization : 
  

  
Women and Children's Hospital of Buffalo
  



  

  
Health Professional
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Our article is misquoted (page 7, lines 283 and 284; reference on page 10 line 388).  We recommend starting dose titration at 500-1000 lipase units/kg/meal. The maximum enzyme dose should be 2500 lipase units/kg/meal, NOT 6,000.  It is very important to correct this error.