Released: January 7, 2025
Level 1 Guidance
Draft
This draft guidance document from the U.S. Food and Drug Administration (FDA) outlines recommendations for the development of drugs and biological products intended for weight reduction and maintenance in both adult and pediatric patients with obesity or overweight and related comorbidities. It provides information on clinical trial design, including subject populations, trial size and duration, and the assessment of efficacy and safety, focusing primarily on sustained weight reduction as an endpoint. The guidance also addresses specific considerations for patients with type 2 diabetes, those experiencing medication-induced weight gain, and the use of combination therapies, while noting that claims beyond weight reduction generally require demonstration of other clinical benefits.
Audio Overview (Google NotebookLM)
(21 minutes 55 seconds)
