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Accelerated Approval For Biomarkers? FDA Considers “Limited Context of Use” To Shorten Qualification Process

This article was originally published in RPM Report

Executive Summary

Biomarker qualification is a hot topic for FDA, industry and Congress, based on the premise that better methods to develop and apply novel biomarkers can be the next big step in helping usher in an era of personalized medicine. One common argument is that the current FDA qualification process is too long. FDA is eager to change that perception.


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