FDA Biomarker Program Needs Overhaul, Genentech Says
Outside experts could provide 'consultation and advice' to sponsors developing qualification plans and to FDA in evaluating qualification submissions.
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In a report both boastful and defensive in tone, the agency explains why some disease areas are rife with targeted therapies while others have few or none.
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.
Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.