FDA
The article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence.
FDA
The new article highlights the aspects of the documentation the authority expects to be submitted for review.
EU
The article provides an overview of the regulatory approach to be applied with respect to clinical investigations involving medical devices in the context of exemptions.
United States
The article provides a brief overview of the existing legal framework associated with the third-party review.
SFDA
The article provides an overview of the regulatory framework for sample collection.
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.
