United States
The article provides a brief overview of the existing legal framework associated with the third-party review.
United States
The highlights the aspects to be taken into consideration in order to ensure the real-world data used to support regulatory submissions is relevant and reliable.
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 provides a brief overview of the approach to be followed for the reports related to studies and reports associated with it.
FDA
The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
