2006P-0209
  

  
 Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
07/10/2006 08:07:40
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I oppose the petition. Laws FDA regulates need enforced, as well. FDA allows the entire label to fulfill 'fair balance' requirements on prescription drug advertisements. An internet website is a DTC ad, with a brief summary too brief. The entire labeling is not visible for each risk and contraindications (in laymen's terms, someone knows the law). The labeling itself misbrands Geodon, and is included.

  


  

  


  

  


  

  



  

  
2006P-0209-EC7-Attach-1.PDF