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ÐÜèÊÓƵComments on Proposed FDA Guidance on Obesity Drugs

Comment Letter

ÐÜèÊÓƵcomments on proposed industry guidance addressing clinical trial design to evaluate new drugs and biological products for weight reduction.

Document Info

Published on Apr 9, 2025

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Resource Details

ÐÜèÊÓƵComments on the proposed guidance on Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction, Guidance for Industry, published in the Federal Register on January 8, 2025.

Overview

Obesity and weight-related complications are critical public health issues in the United States, with tens of millions of Americans overweight and suffering from obesity. ÐÜèÊÓƵagrees with the goals outlined by the Food and Drug Administration (FDA), to design clinical trials that facilitate continued introduction of new drugs and biological products to market that demonstrate sustained weight reduction and improved health.