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# FDA Obesity/Overweight Drug Development Guide
- URL: https://www.fdaweb.com/fda-obesity-overweight-drug-development-guide/
- Published: 2025-01-07T12:00:00.000Z
- Updated: 2026-09-14T14:50:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158434

FDA has published a draft guidance, *Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction*, with recommendations to industry about developing drugs and biologics regulated by CDER intended for reduction and long-term maintenance of body weight in patients with obesity and those with a body mass index classified as overweight who also have weight-related comorbidities. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/obesity-and-overweight-developing-drugs-and-biological-products-weight-reduction?ref=fdaweb.com) says it focuses on the design of trials to demonstrate sustained weight reduction in patients with obesity or overweight.

The guidance includes an Introduction, Clinical Background: Overweight and Obesity, Clinical Assessment of Weight-Reduction Drugs in Adult Patients, Clinical Assessment of Weight-Reduction Drugs in Pediatric Patients, Statistical Considerations, and References.