AAPS J. Mar 2007; 9(1): E105–E108.
© American Association of Pharmaceutical Scientists 2007
Biomarker qualification pilot process at the US Food and Drug Administration
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
Received January 2, 2007; Accepted February 27, 2007.
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.
The Full Text of this article is available as a PDF
These references are in PubMed. This may not be the complete list of references from this article.
1. 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.
2. 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.
3. Goodsaid F, Frueh F. Process map proposal for the validation of genomic biomarkers. Pharmacogenomics. 2006;7:773–773. doi: 10.2217/146224184.108.40.2063. [PubMed] [Cross Ref]
4. 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.
5. 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.