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FDA Delays Release of Guidance on Biomarker Qualification; Aims to Publish by End of Year

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By Adam Bonislawski

The US Food and Drug Administration has delayed the release of its draft guidance on the biomarker qualification process.

Originally slated to be released this summer, the guidance – which will detail the formal steps involved in qualifying biomarkers for FDA approval – will now be put out sometime "before the end of the year," Federico Goodsaid, associate director for operations in genomics at FDA, told ProteoMonitor.

The guidance has been written but must now pass through various levels of approval before its release, he said.

Goodsaid authored an article published in this month's issue of Science Translational Medicine in which he discussed the value of biomarkers in drug development and the FDA's biomarker qualification process.

In particular, he detailed the results of the Critical Path Institute's Predictive Safety Testing Consortium's submission to FDA of urinary protein biomarkers for nephrotoxicity (PM 05/10/2010). He noted that although these markers have yet to be qualified for clinical use, their non-clinical qualification "has already had a positive effect on the sponsors that submit applications for drug approvals, the regulatory agencies that review them, and the public perception about the feasibility and value of biomarker qualification."

FDA, he said, "has already received a number of regulatory submissions" from different pharmaceutical companies making use of the PSTC's nephrotoxicity biomarkers, and several drugmakers are using the "decision trees submitted as part of the qualification" to "accelerate decision making for the interpretation of isolated histopathological findings in some drug safety-evaluation animal models."

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