Alcohol research - Alcoholism: Developing Drugs for Treatment (draft) Guidance for Industry

Alcoholism: Developing Drugs for Treatment (draft) Guidance for Industry, U.S. Department of Health and Human Services Food and Drug Administration Centre for Drug Evaluation and Research (CDER), February 2015 Clinical/Medical 

“I. INTRODUCTION 

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of alcoholism. There are many different terms, definitions, and diagnostic criteria that have been used to describe this condition. However, in this guidance, we use the term alcoholism to describe patients with alcohol use problems that would make them candidates for treatment with medication. As the World Health Organization (WHO) notes, alcoholism is a “term of long-standing use” and is “generally taken to refer to chronic continual drinking or periodic consumption of alcohol which is characterized by impaired control over drinking, frequent episodes of intoxication, and preoccupation with alcohol and the use of alcohol despite adverse consequences.” Further discussion of terminology can be found in Appendix 1.”

See also Links and downloads 

PS For AA Minority Report 2013 click here