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Webcast | Virtual

Event Title
FDA Grand Rounds – Advancing Real-World Evidence in FDA Regulatory Decision Making
December 11, 2025

Date:
December 11, 2025
Time:
12:00 p.m. - 1:00 p.m. ET

Webcast Recording

Recording

Speaker 

Marie Bradley, PhD

Marie Bradley, PhD
Senior Advisor for Real-World Evidence 
Office of Medical Policy
Center for Drug Evaluation and Research 
U.S. Food and Drug Administration

About the Speaker

Dr. Marie Bradley is a Senior Advisor for RWE in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER). Her responsibilities related to real-world evidence (RWE) include serving as lead for the Advancing Real-World Evidence Program, the Real-World Evidence Subcommittee, and a portfolio of RWE demonstration projects. She also evaluates complex RWE-related study protocols submitted to the FDA. Recently, she has been helping to drive Agency level RWE initiatives in the Office of the Commissioner. Dr. Bradley is an established advocate, speaker, and panelist across national and international platforms on RWE-related topics and participates extensively in external engagement. She is a pharmacoepidemiologist and a pharmacist with over 16 years of experience working in regulatory, government, and academic sectors in the U.S. and the UK, including 11 years at the FDA. Dr. Bradley has a doctorate in pharmacoepidemiology and a master’s in pharmacy from Queen’s University Belfast, as well as a Master of Science in public health degree from London School of Hygiene and Tropical Medicine.

About the Presentation

This presentation will explore how the FDA is using real-world data (e.g., data routinely collected in clinical practice) to generate real-world evidence (RWE) to inform regulatory decisions about the effectiveness and safety of medical products. The lecture will cover the evolution of this approach, highlight key activities of the FDA's Real-World Evidence program, and showcase selected guidance documents and demonstration projects that are advancing how we evaluate medical products.

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