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GUIDANCE DOCUMENT

Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction January 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2007-D-0435
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction.”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 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  This guidance revises and replaces the draft guidance for industry “Developing Products for Weight Management” issued in February 2007.

This guidance is being distributed for comment purposes only.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2007-D-0435.

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