CDER Center for Real-World Evidence Innovation (CCRI)

The Center for Real-World Evidence Innovation (CCRI) at the FDA serves as a central hub for advancing and coordinating real-world data (RWD) and real-world evidence (RWE) efforts within the Center for Drug Evaluation and Research (CDER). Its mission is to foster enhanced communication, consistency, and innovation in these activities, including the integration of emerging technologies into both internal and external FDA operations.

CCRI’s key focus areas include:

• Scientific Review and Policy: Driving advancements in the evaluation and regulation of RWD and RWE.
• Coordinated Outreach and Engagement: Facilitating collaboration with stakeholders.
• Regulatory Science Initiatives: Supporting innovation in regulatory practices.
• Knowledge Management: Streamlining information sharing and expertise development.

Stakeholders can subscribe to the CCRI email list for updates and insights. Additionally, the CBER/CDER RWE Program and the Advancing RWE Program offer detailed information on ongoing projects and opportunities for sponsors to engage.

Region: United States of America

Source: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-real-world-evidence-innovation-ccri