The EMA published its OPTIMAL framework for the use of RWE in 2019 and recently set up a coordination center for the Data Analysis and Real World Interrogation Network (DARWIN EU). Does it mean the FDA is a little bit slower in leveraging RWE? Are there any publications to compare different HAs' responses? Have you experienced different decisions coming from the same evidence? And are there any withdrawal rate differences in different markets for the same medicine?
Thanks,
Yuwei
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Yuwei Zhang
Waltham MA
United States
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