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Keyword Search Criteria: real-world data returned 2 record(s)
Monday, 07/30/2018
Use of Real-World Data and Real-World Evidence for Regulatory Decisions: Opportunities and Challenges
Lilly Yue, U.S. Food and Drug Administration; Nelson Lu, U.S. Food and Drug Administration; Yunling Xu, FDA/CDRH
10:35 AM

A Propensity Score Stratified Bayesian Power Prior Approach for Incorporating Real-World Evidence in Single Group Medical Device Clinical Studies
Chenguang Wang, John Hopkins University; Ram Tiwari, Center for Devices and Radiologica Health, FDA; Lilly Yue, U.S. Food and Drug Administration; Yunling Xu, FDA/CDRH
10:55 AM