FDA
The new article further describes in detail the scope of matters covered by the guidance, as well as the relevant legal background.
Australia
The new article clarifies the exclusion requirements for the software products intended to be used for communication purposes, as well as for administration of healthcare facilities.
Australia
The new article provides further clarification regarding the regulatory status of the software products intended to be used for patient image transmission, alerts for healthcare professionals, and clinical workflow management.
FDA
The new article clarifies the regulatory approach to be applied with respect to tailored responsive communication.
FDA
The new article explains the matters related to general medical product communication in the context of addressing misinformation about the products.
Denmark
The article outlines the key points to be included in the application for authorization to conduct clinical trials in Denmark.
