2003D-0570 - Guidance for Industry: GUIDANCE FOR THE CLINICAL EVALUATION OF WEIGHT- CONTROL DRUGS; Availability
FDA Comment Number : EC3
Submitter : Dr. George Bray Date & Time: 04/19/2004 03:04:23
Organization : Pennington Biomedical Research Center
Academia
Category :
Issue Areas/Comments
GENERAL
GENERAL
We view the procedures for evaluating a drug in the treatment of obesity as an opportunity to demonstrate the efficacy of the drug and its high level of safety; considering the population in which it will be used, we also view this process as a basis for developing information about the use of a drug by physicians in the practice of medicine and the care of their patients.