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COPD Patient-Reported Outcome Questionnaire Is Early Example of FDA Drug Development Tool “Approval” Process

This article was originally published in RPM Report

Executive Summary

FDA finalizes the "qualification process for drug development tools." The topic won't get as much attention as Breakthrough Therapy or Accelerated Approval, but the head of the drug center thinks this is a very big deal. A COPD outcomes assessment is an early example of the process in action.

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