FDA Draft Guidance on Third Party Review Program: FDA Expectations
The article addresses the aspects related to the authority’s expectations associated with the respective program.
The article addresses the aspects related to the authority’s expectations associated with the respective program.
The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting.
The new article highlights the aspects related to the review process itself.
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.