banter and General Discussion, page-9460

I see there is Interest in FDA changes in data views...

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Thursday, April 25, 202412:30 PM - 1:30 PM ESTApplying Real-World Data: Use cases and FDA guidanceAchieving more pragmatic approaches to clinical evidence generation requires an understanding of potential approaches and regulatory acceptance of such approaches. This webinar will review recent FDA draft guidance regarding the use of RWD/RWE in medical device studies that outline approaches and considerations for more pragmatic research. The webinar will also delve into case studies of companies leveraging RWE, highlighting how each case accounts for regulatory guidance and acceptance