Advancing Regulatory Science through Novel Biomarker Research and Science-Based Technologies

As a key component of FDA's Advancing Regulatory Science Initiative, the Office of Critical Path Programs (OCPP) supports innovation in the development, evaluation, and manufacture of new safe and effective medical/veterinary products for diagnosing, treating, and preventing diseases. This Funding Opportunity Announcement (FOA) invites applications that propose applying novel technologies and approaches to developing new biomarkers for well defined human or veterinary diseases and toxicity in areas where an unmet need exists, particularly where such biomarkers show substantial promise to enable or speed product development and evaluation or improve patient effectiveness and healthcare outcomes as well as ensure product availability to patients in a timely manner.Applications should address the Critical Path Initiative mission to facilitate the development of new safe and effective products for diagnosing, treating, and preventing disease.