Biomarker qualification pilot process at the US Food and Drug Administration
- 1 March 2007
- journal article
- Published by Springer Nature in The AAPS Journal
- Vol. 9 (1), E105-E108
- https://doi.org/10.1208/aapsj0901010
Abstract
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.Keywords
This publication has 1 reference indexed in Scilit:
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