FDA Draft Guidance on Real-World Evidence: Specific Aspects
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.
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.
The new article addresses the aspects related to various matters associated with the licensing process for establishment licenses.
This article highlights the aspects related to the approach to be applied when determining whether a notification is required.
The present article describes in detail the policy followed by the authority concerning specific supplements.
The article highlights the key points associated with the electronic submissions template described by the US authority.
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