Pathways for Regulatory Innovation and Strategic Modernization (PRISM)

The Pathways for Regulatory Innovation and Strategic Modernization (PRISM) cooperative agreement is intended to advance public health by strengthening the scientific, collaborative, and operational foundations needed to modernize regulatory oversight in an increasingly complex and rapidly evolving public health landscape. As innovation in medical products, diagnostics, foods, and digital health accelerates, our nation must continuously adapt its regulatory science approaches to ensure timely access to safe, effective, and high-quality products for the American public. PRISM is designed to support this modernization by enabling forward-looking, non-regulatory collaborations that align with the Commissioner’s strategic priorities and the Administration’s broader public health goals.

PRISM provides a flexible, scalable approach to patient, consumer, industry, academia, and healthcare workforce engagement to generate applied scientific knowledge, tools, and approaches that enhance regulatory predictability, efficiency, and transparency. By leveraging independent expertise and real-world insights, PRISM bridges gaps between innovation and regulation to optimize uptake of emerging technologies, evolving consumer needs, and new sources of evidence such as real-world data and real-world evidence.