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.
CDC’s advisory committee also approves a VFC program update allowing for the rare, off-label use of tetanus toxoid- and diphtheria toxoid-containing vaccine in young children, and plans to move up timing of its COVID-19 vaccine recommendations for the 2024-2025 formulation.