MHRA
The new article describes in detail the specific requirements an application should meet, as well as the relevant steps and procedures.
BfArM
The article addresses the aspects related to data protection in the context of digital health applications.
FDA
The article highlights the key points related to the application process and outlines the most important aspects to be taken into consideration by applicants.
FDA
The article provides an overview of the revised guidance document issued by the US authority to address certain regulatory matters and ensure legal clarity.
EU
The article provides an overview of the approach to be applied when calculating regulatory fees associated with registration and authorization for medicines intended to be marketed and used in Ireland.
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
