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Specifically, this NOFO willsupport analytical and/or clinical validationof a biomarker, composite biomarker or biomarker signature, withrigor comparable with the expectations described in the Food and Drug Administration (FDA)Biomarker Qualification Program (BQP) or recommended by other FDA regulatory pathways.Link to Additional Information:

Moreover, it develops data entry protocols that allow for review of data quality, data analyses, and composition of clinical study reports with the intent for submission to the FDA and other relevant regulatory authorities.