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 outlines the scope of information to be included in premarket submissions depending on the sterilization methods used.
