2000D-1350 - Draft Guidance for Industry on Labeling for Combined Oral Contraceptives; Availability
  


  

  


  

  
FDA Comment Number : 
  

  
EC4
  



  

  

  



  

  
Submitter : 
  

  
Dr. James  Shelton
  

  
Date & Time: 
  

  
05/06/2004 07:05:05
  



  

  
Organization : 
  

  
US Agency for International Development
  



  

  
Federal Government
  


  

  
Category : 
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 



I'd like to complement you on the many improvements in this OC labeling guidance based on evidence.  I especially like the strengthened warning related to smoking, and the overall simplification of the patient labeling.



However, I believe the labeling can be improved further.



See attached for specific comments.



Jim Shelton