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FDA, NIH release joint guidance for biomarker qualification

By Mark McCarty
Regulatory Editor

Wednesday, December 14, 2016

The FDA and the NIH now have 21st Century Cures expectations to deal with, a task that may be easier to manage thanks to a joint framework the two agencies recently published regarding the evidentiary criteria for biomarker qualification. The document notes that its provisions apply to "all categories of biomarkers and contexts of use," and that the document will be used by FDA to develop guidances relating to biomarker qualification.

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