2006N-0062
  

  
Expanded Access to Investigational Drugs for Treatment Use
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC5
  



  

  
Submitter : 
  

  
Dr. Max Fink
  

  
Date & Time: 
  

  
12/26/2006 06:12:11
  



  

  
Organization : 
  

  
SUNY at Stony Brook
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 A personal interest in the experimental agent PIRFENIDONE in the relief of IDIOPATHIC PULMONARY FIBROSIS leads me to suggest that such agents should be made available to practitioners at the earliest opportunity. IPF is a fatal disorder for which no treatment is known. 

When the safety data are encouraging for trials,  as it is for this compound, individual experiments should be encouraged when individual physicians accept repsonsibility for the care and the patient is competent to give informed consent.