| 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 | ||||||||||||||||||||||
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| 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. | |||||||||||||||||||||||