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American Course on Drug Development and Regulatory Sciences (ACDRS)
University of California, San Francisco
W e b i n a r A n n o u n c e m e n t
Role of Real-World Evidence in Regulatory Decision-Making Before, During, and After COVID
Nirosha Mahendraratnam Lederer, PhD, MSPH
Director, RWE Strategy
COVID-19 has disrupted drug development, evidence generation, and care-delivery. This presentation will provide an overview of how COVID-19 has accelerated the generation and adoption of RWD/RWE for drug development and its potential for the future.
The Use of Real-World Data for Prescription Drug Regulatory Questions
Mark Levenson, PhD
Director, Division of Biometrics VII
Office of Biostatistics
US Food and Drug Administration
Emerging sources of digital health data, including electronic medical records, app-based data, and wearable device data, may be leveraged to address regulatory questions concerning prescription drugs. FDA has extensive experience using digital health data to address questions on the safety of drugs. More recently, FDA has initiated efforts to explore the use of these data sources, known as real-world data, to address questions on the efficacy of drugs. This talk will review these efforts and apply the regulatory standard for the demonstration of efficacy to the evaluation of studies based on real-world data.
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