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Biomarker qualification pilot process at the US Food and Drug Administration

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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

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Authors and Affiliations

  1. 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

    Federico Goodsaid & Felix Frueh

Authors
  1. Federico Goodsaid
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  2. Felix Frueh
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Correspondence to Federico Goodsaid.

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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

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