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.