This opportunity seeks a vendor to provide regulatory innovation and strategic modernization pathways services through the PRISM cooperative agreement. The initiative aims to advance public health by reinforcing scientific, collaborative, and operational frameworks essential for modernizing regulatory oversight in a rapidly evolving public health environment.

Vendors will support efforts to enable the nation to adapt regulatory science approaches for ensuring timely access to safe, effective, and high-quality products, including products, diagnostics, foods, and digital health. The selected provider will focus on advancing the use of real-world data, real-world evidence, and artificial intelligence to enhance public health and regulatory science. Additionally, strengthening access pathways for patients to investigational therapies, such as through expanded access programs, is a core element of the project.