Description
The Pathways for Regulatory Innovation and Strategic Modernization (PRISM) cooperative agreement aims 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. The project will support non-regulatory, science-driven activities that align with FDA's public health goals and priorities. Key areas of focus include advancing the use of real-world data, real-world evidence, and artificial intelligence to inform public health and regulatory science, strengthening pathways for patient access to investigational therapies, and promoting gold-standard, evidence-based approaches across regulatory science domains. The recipient will be expected to generate applied scientific knowledge, tools, and approaches that enhance regulatory predictability, efficiency, and transparency.
Some of the key activities that will be supported under this cooperative agreement include:
• Convenings, workshops, and public forums to share expertise and identify emerging scientific and operational challenges
• Applied research and methodological exploration to support modern regulatory science approaches
• Development and dissemination of tools, frameworks, and best practices that enhance regulatory predictability, efficiency, and transparency
• Analysis of real-world experiences and data to inform improvements in regulatory science and public health outcomes