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.
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References
US Food and Drug Administration.Guidance for industry— pharmacogenomic data submissions. Available at: http://www.fda.gov/cder/guidance/6400fnl.pdf. Accessed October 25, 2006.
US Food and Drug Administration.Table of valid genomic biomarkers in the context of approved drug labels. Available at: http://www.fda.gov/cder/genomics/genomic_biomarkers_table.htm. Accessed October 25, 2006.
Goodsaid F, Frueh F. Process map proposal for the validation of genomic biomarkers.Pharmacogenomics. 2006;7:773.
Clinton P, Wechsler J. What Ever Happened to Critical Path.Pharmaceutical Executive. 2006; Available at: http://www.pharmexec. com/pharmexec/article/article Detail.jsp?id=282481&pageID=6. Accessed November 12, 2006.
US Food and Drug Administration.Predictive Safety Testing Consortium. Available at: http://www.fda.gov/oc/initiatives/criticalpath/projectsummary/consortium.html. Accessed October 25, 2006.
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Published: March 23, 2007
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Goodsaid, F., Frueh, F. Biomarker qualification pilot process at the US Food and Drug Administration. AAPS J 9, 10 (2007). https://doi.org/10.1208/aapsj0901010
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DOI: https://doi.org/10.1208/aapsj0901010