Biomarkers Qualification: Can FDA Get Rolling Before A Push From Congress?
FDA has been reluctant to lay out evidentiary standards for biomarker qualification, but its call for information on promising candidates may be an initial step toward creating such a framework.
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Newspaper ad from Manhattan Institute picks up on themes contained in think tank's recent Project FDA report aimed at speeding development and use of biomarkers.
Outside experts could provide 'consultation and advice' to sponsors developing qualification plans and to FDA in evaluating qualification submissions.