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Tuesday, 04/03/2018 1:07:07 AM

Tuesday, April 03, 2018 1:07:07 AM

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Remarks by Dr. Gottlieb to the National Academy of Sciences on the Impact of Real World Evidence on Medical Product Development
Real world evidence, real world data and clinical registries

"Last month, we issued final guidance on the use of RWE in the development of devices...in some cases saving one to two years of development time. Increasingly, medical device makers are also meeting their post-market study requirements by leveraging real world data sources.

https://www.fda.gov/NewsEvents/Speeches/ucm576519.htm
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