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  5. DDT COA #000110: WHO Risk Drinking Levels of Alcohol Consumption
  1. Drug Development Tool (DDT) Qualification Programs

DDT COA #000110: WHO Risk Drinking Levels of Alcohol Consumption

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Anesthesia, Addiction Medicine, and Pain Medicine (DAAP)

DDT COA Number
DDT COA #000110

Instrument Name
WHO Risk Drinking Levels of Alcohol Consumption

Disease/Condition
Alcohol use disorder (AUD)

Concept of Interest
WHO 2-level risk drinking reduction

Context of Use
Patients diagnosed with an AUD

COA Type
PRO

Qualification Stage
Letter of Intent- Accepted 

Requestor(s)
The Alcohol Clinical Trials Initiative (Active)

Contact(s)
Raye Litten

Date Accepted into CDER’s COA Qualification Program
April 23, 2019

Submission and Regulatory Correspondence History


Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

Letter of Intent

2/14/19

FDA Response (Accepted)

4/23/19