Impact to the Bioanalytical Community of the FDA Issuance of the Draft Guidance on Biomarker Qualification: Evidentiary Framework

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The FDA released a Draft Guidance in December (2018) on the evidentiary framework and standards required to achieve qualified biomarkers.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  As such, this Draft Guidance supports the Qualification of Drug Development Tools section (507) of the 21st Century Cures Act enacted on December 13, 2016 and provides the framework for developing the data set (evidence) supporting designation of a biomarker as qualified for a particular context of use (COU). Within this context of use, the qualified biomarker, “…can be relied on to have a specific interpretation and application in drug development and regulatory review…” While biomarkers measured by medical devices are outside the scope of the Draft Guidance, the Agency broadens the practical scope beyond qualified biomarkers to include the evidence needed to support the use of biomarkers in INDs, NDAs and BLAs:

“Many principles discussed in this guidance could also be appropriate when considering the evidence scientifically sufficient to support the use of a biomarker in an individual drug development program (e.g., investigational new drug application, new drug application, or biologics license application submissions).” Continue reading