FDA Releases Draft Guidance Document on Use of Histology in Biomarker Qualification Studies

The US Food and Drug Administration (FDA) released Friday a new draft guidance titled, Use of Histology in Biomarker Qualification Studies.

The document outlines the processes that industry should use to ensure histology data is accurate, sound, and adheres to scientific standards for biomarker characterization and qualification.

The FDA is hoping to provide clarity to the biomarker development process to spur successful product development, as outlined in its Critical Path Initiative.  Biomarkers broadly apply to the molecular structure, biochemical measurements, and organ system functions of the body.

The guidance notes that, "if a biomarker becomes qualified, analytically valid measurements of it can be relied upon to have a specific and interpretable meaning in drug development and regulatory decision-making."  This would be mutually beneficial to both the FDA and to industry in speeding up the development time and premarket review of the substance.

The Federal Register posting for the draft guidance also notes that the draft guidance is aimed at reducing the instances of unqualified biomarkers, which "can do considerable harm" to the drug development process by promoting an "erroneous perception of safety" and an inadequate risk-benefit profile that is unlikely to be approved by the FDA.

• (FDA - Draft Guidance)
• (Federal Register)
• (Critical Path Initiative)