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

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The US Food and Drug Administration has delayed the release of its draft guidance on the biomarker qualification process.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

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