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Questions and answers about the Pilot Process for Biomarker Qualification at the FDA
Federico M Goodsaid1, Felix W Frueh1
1Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.
Abstract:
The FDA has developed a Pilot Process for Biomarker Qualification. Initial experience with this process has underscored the care that a long-term approach to biomarker qualification independently of development for specific drugs should have in the assembly of external industry consortia as well as the internal regulatory organization for these qualification efforts. There are complex scientific and clinical issues associated with these qualifications, and it is paramount that the expertise needed for their review be identified so that a comprehensive consensus may be reached at the end of this process. Several frequently asked questions associated with this process are presented in this paper, as well as answers reflecting the Agency's current thinking about this process.:
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