FDA provides an overview of initiatives involving real-word data (RWD) and real-world evidence (RWE) and shares a regulatory frameworks for RWE with regard to drugs, biologics, and devices. Speakers discuss opportunities and challenges when using RWD focusing specifically on the use of RWE to support regulatory decisions in the FDA’s efforts to explore the potential for leveraging the vast amount of data generated in the health care system to protect and promote the public health.

Presenters:
John Concato, Deputy Director
Office of Medical Policy Initiatives
Center for Drug Evaluation and Research (CDER)

Soma Kalb, Director
Division of Clinical Evaluation and Analysis 1: Clinical Science and Quality
Office of Clinical Evaluation and Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health (CDRH)

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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