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Current Status of FDA Framework for the Evaluation of Real World Evidence
Session Chair(s)
M. Khair ElZarrad, PHD, MPH
Vice President, Regulatory Policy, BridgeBio, United States
FDA issued a framework for a program that will evaluate the use of real world evidence (RWE) to help support the approval of new indications for an approved drug or to help support or satisfy drug post approval study requirements. During this session, FDA will share their takeaways from public comments about the RWE framework and provide participants with an update on the current status of the FDA RWE Program.
Learning Objective : Identify three topic areas included in the FDA real world evidence program; Identify and discuss two FDA takeaways from the analysis of public comments to the real world evidence framework; Identify one area of interest for real world evidence guidance development.
Speaker(s)
FDA Update
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, United States
Update from CBER
Director, Office of Biostatistics and Epidemiology, CBER, FDA, United States
FDA Update
Vice President, Head, PCO Center of Excellence, Novartis, United States
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