2003D-0570 - Guidance for Industry: GUIDANCE FOR THE CLINICAL EVALUATION OF WEIGHT- CONTROL DRUGS; Availability

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2
  



  

  

  



  

  
Submitter : 
  

  
Dr. Julie Krop
  

  
Date & Time: 
  

  
03/30/2004 05:03:07
  



  

  
Organization : 
  

  
Peptimmune, Inc.
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 1. Expectation of a 6 week run in period with plateau of weight prior to randomization is very unrealistic as a requirement for phase 2/3 weight loss studies-

2. Given current obesity epidemic and need for new therapys, agents with limited toxicity concerns should be able to file for approval with 1 year data and allowed to submit 2 year data during approval process.