US FDA Guidance Redefines Obesity, But Keeps 2007 Efficacy Standard

The US Food and Drug Administration updated obesity drug development draft guidance for the first time in almost 20 years and although a lot has changed in the field, the FDA’s fundamental expectations to support approval did not.

The FDA did not update its efficacy expectations for weight loss drugs in new draft guidance. (Shutterstock)

Key Takeaways

New FDA draft guidance on obesity drug development defines the condition as a disease for the first time.

The US Food and Drug Administration formally defined obesity as a “disease” in an updated draft guidance for drug developers.

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