Compliance, Regulatory Requirements, Healthcare
8 Jan 2025
pharmaceuticals, fda, drug development, obesity, weight reduction
🏥FDA Announces Guidance on Developing Obesity Treatment Drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction." This draft guidance provides recommendations to industry regarding the development of drugs and biological products regulated within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or overweight. This draft guidance revises and replaces the draft guidance for industry "Developing Products for Weight Management" issued in February 2007.
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