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 highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
FDA
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
FDA
The new article highlights the aspects related to the content and format of an application for initial recognition and re-recognition as a third-party 510k review organisation.
FDA
The new article highlights the aspects related to the review process itself.
