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Keyword Search Criteria: FDA returned 5 record(s)
Sunday, 07/29/2018
Real World Evidence Demonstration Projects and Policy Development at FDA
Diqiong Xie, FDA; David Barrett Martin, FDA CDER OMP
4:45 PM

Monday, 07/30/2018
The Role of Real World Evidence in a Regulatory Environment: Focus on Safety
Estelle Russek-Cohen, US FDA CDER
8:35 AM

Tuesday, 07/31/2018
Completion Rates and Considerations for Analyses of Patient-Reported Outcomes in Open-Label Cancer Trials: FDA Review of Trials, 2007 - 2017
Jessica K. Roydhouse, Office of Hematology and Oncology Products, US Food and Drug Administration; Mallorie H. Fiero, Office of Biostatistics, US Food and Drug Administration; Bellinda King-Kallimanis, Office of Hematology and Oncology Products, US Food and Drug Administration; Paul G. Kluetz, Oncology Center of Excellence, US Food and Drug Administration


Quantitative Regulatory Landscape
Lothar Tremmel, CSL Behring
8:35 AM

Wednesday, 08/01/2018
Addressing Missing Accelerometer Data with Functional Data Analysis (FDA)
Patrick Hilden; Joseph Schwartz, Columbia University; Jeff Goldsmith, Columbia University
10:05 AM