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Impact to the bioanalytical community of the FDA issuance of the draft guidance on biomarker qualification: evidentiary framework

The FDA released a Draft Guidance in December (2018) on the evidentiary framework and standards required to achieve qualified biomarkers.  It is intended to cover a regulatory gap related to the use of biomarkers outside of specific drug programs.  As such, this Draft Guidance supports the Qualification of Drug Development Tools …