2004D-0042 - Draft Guidance for Industry on Improving Information About Medical Products and Health Conditions; Withdrawal; Availability

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC14
  



  

  

  



  

  
Submitter : 
  

  
Mr. David McAvoy
  

  
Date & Time: 
  

  
09/16/2004 06:09:03
  



  

  
Organization : 
  

  
Eli Lilly and Company
  



  

  
Drug Industry
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Eli Lilly and Company wishes to submit to the public docket separate written comments on the FDA draft guidances for communicating risk information in consumer prints ads and for help-seeking ads. Lilly has just completed a research study on disclosure of print ads and received the results only as of August 6. Lilly has completed a preliminary analysis of these data and will submit written comments tonight; however, we are experiencing technical difficulties with our company's computer network. We anticipate still submitting these comments by midnight, August 10 (EST). As for the Lilly help-seeking ad comments, these will be submitted by close of business, August 13.