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Time For LUFA? Lab-Developed Test Policy Will Be Key Piece Of 2017 FDA Law

This article was originally published in RPM Report

Executive Summary

FDA is hoping to set up yet another user fee program—this one for lab-developed test oversight—when the next user fee legislation is enacted in 2017. The labs aren’t ready to negotiate yet, but the issue is going to be an important area for biopharma to monitor as the transition to personalized medicine continues.

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