🏥FDA Announces Guidance on Developing Obesity Treatment Drugs
Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction." This draft guidance provides recommendations to industry regarding the development of drugs and biological products regulated within the Center for Drug Evaluation and Research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 This draft guidance revises and replaces the draft guidance for industry "Developing Products for Weight Management" issued in February 2007.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance from the FDA outlines regulatory requirements for the development of weight reduction drugs and biological products, which directly impacts pharmaceutical companies and other stakeholders in the healthcare sector. This guidance updates prior regulations, indicating a shift in compliance obligations and opportunities for innovation in obesity management products.