Drugs

Biomarker Context of Use Post

An FDA biomarker qualification program online post says that a biomarker context of use (CoU) “is a statement that describes the manner and purpose of use for the biomarker in drug development. The supporting data and analyses submitted with the biomarker qualification submission determine the acceptability of the qualified CoU.”

The post notes that each biomarker category can have a variety of CoUs. For example, it says, a prognostic biomarker can be used for patient stratification or enrichment in clinical trials. Each biomarker qualification submission is to specifically state the CoU for which it is seeking qualification.

CoUs can be revised during the qualification process, FDA says, and the availability of supporting data to substantiate the proposed CoU is critical.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome