Biomarker qualification pilot process at the US Food and Drug Administration

Author:

Goodsaid Federico,Frueh Felix

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference5 articles.

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.

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.

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