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Zdrowie i gospodarka · 15.02.2007

Draft Guidance for Industry on Developing Products for Weight Management; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Developing Products for Weight Management." FDA is interested in updating the September 1996 draft guidance entitled "Guidance for the Clinical Evaluation of Weight-Control Drugs" by incorporating the latest scientific and clinical advances in the drug development field of obesity, including recommendations on the development of products for weight management in pediatric patients and in patients with medication-induced weight gain, and recommendations on the development of combinations of weight-management products. This action is expected to provide clear and consistent advice to those in industry who are interested in developing weight-management products.

Source: Federal Register — Food and Drug AdministrationOpen original release →