This guidance provides recommendations to industry regarding the development of drugs and therapeutic biologics (hereafter products) regulated within the Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) for the indication of weight management. This guidance applies to products intended to be used for medical weight loss, which can be defined as a long-term reduction in fat mass with a goal of reduced morbidity and mortality through quantifiable improvements in biomarkers such as blood pressure, lipids, and HbA1c. This guidance revises the draft Guidance for the Clinical Evaluation of Weight-Control Drugs that issued in September 1996. When finalized, this guidance will replace the September 1996 draft guidance.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.