Type:Notice
Citation:90 FR 1502
Reading Time:about 6 minutes
The FDA has released a draft guidance titled "Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction" for public comment. This draft provides recommendations for developing drugs aimed at long-term weight loss and maintenance for individuals with obesity or overweight. It updates a previous guidance issued in 2007 and covers aspects like trial design, participant selection, and safety evaluations. The public can submit comments on the draft until April 8, 2025, to help shape the final version.
Simple Explanation
The FDA has shared a draft plan that gives tips on how to make new medicines to help people lose weight and keep it off. People can read this plan and tell the FDA what they think until April 8, 2025.