Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned - 09/23/2025

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Good morning, and thank you for being here.

At FDA, our work is guided by two principles: application of common-sense approaches to problem solving and adherence to gold standard science. Our approach to RWE is no different. During the meeting today, we will have the opportunity to look back at how real-world evidence (RWE) has already informed regulatory decision-making across the Agency-and to look forward at how each of our Centers aspires to build on that progress in the years ahead.

Throughout the day, you'll hear directly from Centers across FDA. They will share their experiences with RWE-where it has made a difference-and their vision for what comes next.

This conversation also resonates with the HHS MAHA Strategy Report, which highlights national priorities in pediatric health, mental health, allergy and nutrition, rare diseases, health equity, and artificial intelligence. These themes align closely with FDA's own priorities, and RWE is the bridge that connects them:

• Harnessing Big Data - MAHA calls for a deeper understanding of pediatric health, chronic conditions, and disparities. RWE allows us to study large, diverse datasets from real-world settings, revealing treatment patterns, safety signals, and gaps in care that clinical trials alone may not capture.
• Accelerating Cures - MAHA emphasizes faster, more equitable access to therapies, especially for rare diseases and vulnerable populations. RWE can complement trials to provide the additional evidence regulators need-helping FDA bring safe and effective treatments to patients more quickly, without compromising rigor.
• Unleashing AI - MAHA highlights AI as a driver of innovation. Applied to real-world data, AI and advanced analytics can generate insights at scale, modernize review processes, and even support innovative methods such as predictive modeling for safety and effectiveness.

We are already taking important steps. For example, FDA has published new examples on our website showing how CDER and CBER have used RWE in regulatory decisions-complementing CDRH's comprehensive report on its use of real-world evidence. At the agency-wide level, we have launched FDA-RWE-ACCELERATE: the first FDA-wide initiative dedicated to advancing the integration of real-world evidence into regulatory decision-making. ACCELERATE brings together experts from across all Centers, strengthens

information exchange, and ensures that RWE is applied consistently and effectively across the Agency. And to support these efforts with cutting-edge tools, we are building Sentinel 3.0, a modernized system designed to harness advanced data science and analytics to detect safety signals earlier, generate evidence more efficiently, and better inform regulatory decisions.

As today's discussions unfold, these themes will surface again and again-demonstrating how FDA's use of RWE connects both to our Agency's mission and to the nation's broader health strategy.

The goal of this meeting is not only to take stock of what we've achieved, but also to look forward: to learn from one another, to hear each Center's aspirations, and to chart a path toward a more agile, modern FDA-one that delivers on the most pressing health needs of the nation.

Thank you again for your engagement. I look forward to the discussions ahead.

• Content current as of:

  09/25/2025

• Regulated Product(s)

  • Drugs