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  1. Drug Development Tool (DDT) Qualification Programs

pDDT COA #2019-01: PostopQRS

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) II
Division of Anesthesia, Analgesia, and Addiction Products (DAAAP)

DDT COA Number
pDDT COA #2019-01

Instrument Name
PostopQRS

Disease/Condition
Recovery from surgery and anesthesia

Concept of Interest
Recovery process

Context of Use
Patients undergoing all forms of surgery and anesthesia

COA Type
PRO, PerfO, and ClinRO

Qualification Stage
Letter of Intent- Not Accepted

Requestor(s)
Stanton Newman

Contact(s)
Stanton Newman

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

Letter of Intent

1/30/19

FDA Response (Not Accepted)

4/29/19

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