Biomarker qualification pilot process at the US Food and Drug Administration
New biomarkers of safety and efficacy are becoming powerful tools in drug development. Their application can be accelerated if a consensus can be reached about their qualification for regulatory applications. This consensus requires a review structure within the US Food and Drug Administration (FDA) that can evaluate qualification data for these biomarkers and determine whether these biomarkers can be qualified. A pilot process and corresponding Biomarker Qualification Review Team have been developed to test how the FDA can work on biomarker qualification.
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- Biomarker qualification pilot process at the US Food and Drug Administration
The AAPS Journal
Volume 9, Issue 1 , pp E105-E108
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- 1. Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Building 21, Room 3663, 20903-0002, Silver Spring, MD