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  5. DDT COA #000004: PerfO to assess instrumental activities of daily living (IADLs)
  1. Drug Development Tool Qualification Programs

DDT COA #000004: PerfO to assess instrumental activities of daily living (IADLs)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) I
Division of Neurology Products (DNP)

DDT COA Number
DDT COA #000004

Instrument Name
PerfO to assess instrumental activities of daily living (IADLs)

Disease/Condition
Alzheimer’s Disease

Concept of Interest
Day to day functioning

Context of Use
Adults (>45 years) with mild cognitive impairment due to Alzheimer’s Disease

COA Type
PerfO

Qualification Stage
Letter of Intent-Accepted 

Requestor(s)
Critical Path Institute: Patient-Reported Outcome (PRO) Consortium, Cognition Working Group

Contact(s)
Stephen Coons

Date Accepted into CDER’s COA Qualification Program
March 18, 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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