US FDA Guidance Redefines Obesity, But Keeps 2007 Efficacy Standard

 
• By Michael McCaughan

The US Food and Drug Administration updated obesity drug development draft guidance for the first time in almost 20 years and although a lot has changed in the field, the FDA’s fundamental expectations to support approval did not.

The FDA did not update its efficacy expectations for weight loss drugs in new draft guidance.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

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Michael McCaughan is a founding member of Prevision Policy LLC, a leading provider of regulatory and reimbursement policy analysis for the biopharma industry. He was previously the Editor-In-Chief of The Pink Sheet and remains a contributor to the publication.

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