FDA Biomarker Program Needs Overhaul, Genentech Says
This article was originally published in The Gray Sheet
Outside experts could provide 'consultation and advice' to sponsors developing qualification plans and to FDA in evaluating qualification submissions.
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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.