Navigating the 2025 FDA Biomarker Guidance: Key Insights for Successful Validation

The newly released 2025 FDA Biomarker Guidance marks a pivotal step forward in the regulation of biomarker bioanalysis, offering a long-anticipated alternative to the 2018 Bioanalytical Method Validation Guidance. However, the document stops short of delivering clear direction on how to effectively validate biomarker assays—particularly in areas that fall outside the scope of traditional drug bioanalysis and the 2022 M10 Guidance.

This report highlights the critical challenges presented by the 2025 guidance, including the lack of specificity around context of use (COU), limited assay coverage and the ambiguity in validation expectations. These gaps may lead to inconsistent data across trials and increase the risk of regulatory missteps—especially when working with novel biomarkers or emerging assay technologies.

As contract research organizations (CROs) become the linchpin in regulatory strategy, their ability to interpret COU and apply flexible, scientifically sound validation approaches becomes essential. With over 75 years of combined experience, we offer the expertise and client-focused service needed to navigate this evolving landscape.

Download our full report to explore key insights and learn how we can support your biomarker validation strategies under the 2025 guidance.

Download the Report