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Alcoholism: Developing Drugs for Treatment February 2015


Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the 20 treatment of alcoholism. There are many different terms, definitions, and diagnostic criteria that 21 have been used to describe this condition. However, in this guidance, we use the term 22 alcoholism to describe patients with alcohol use problems that would make them candidates for 23 treatment with medication. As the World Health Organization (WHO) notes,3 alcoholism is a 24 “term of long-standing use” and is “generally taken to refer to chronic continual drinking or 25 periodic consumption of alcohol which is characterized by impaired control over drinking, 26 frequent episodes of intoxication, and preoccupation with alcohol and the use of alcohol despite 27 adverse consequences.”

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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:

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

All comments should be identified with the title of the guidance.