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  5. DDT COA #000083: Acute Otitis Media Severity of Symptoms Scale (AOM-SOS)
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DDT COA #000083: Acute Otitis Media Severity of Symptoms Scale (AOM-SOS)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) II
Division of Metabolism and Endocrinology Products (DMEP)

DDT COA Number
DDT COA #000083

Instrument Name
Acute Otitis media Severity of Symptoms Scale (AOM-SOS)

Disease/Condition
Acute otitis media

Concept of Interest
acute otitis media symptoms

Context of Use
Children with acute otitis media

COA Type
ObsRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Nader Shaikh
Alejandro Hoberman

Contact(s)
Nader Shaikh

Date Accepted into CDER’s COA Qualification Program
November 16, 2015

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

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Transition Letter to 507 Process

9/5/19

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