FDA
The article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence.
FDA
The new article highlights the aspects of the documentation the authority expects to be submitted for review.
United States
The new article highlights the aspects related to how the regulatory context should be considered when assessing real-world evidence and real-world data.
FDA
The article provides a brief overview of the applicable regulatory requirements related to using real-world data in the context of submissions associated with medical devices intended to be marketed and used in the US.
FDA
The article highlights the key points related to the specific aspects to be considered when using real-world data to support marketing applications related to medical devices.
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