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Patient Advocacy And PDUFA VI: Next Steps Could Include Involvement In Reviews, More Scientific Briefings for FDA Staff

This article was originally published in RPM Report

Executive Summary

Disease advocacy organizations are expanding their “honest broker” function in drug development into the early stages of the regulatory discussions. They are engaging in the patient-focused meetings established by PDUFA V and finding more ways to interact with FDA review staff on general development issues in their specific areas. That may become the model for building on the patient input process in the next user fee agreement.

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