FDA
The new article provides additional clarifications with respect to the development of use-related risk analyses.
FDA
The new article elaborates further on the submission of use-related risk analyses, and also provides certain examples intended to demonstrate the way the regulatory approach described in the guidance should be applied.
FDA
The article highlights the key points regarding the approach to be followed in order to ensure healthcare professionals and patients are provided with accurate, factually correct, and up-to-date information about healthcare products.
FDA
The new article further describes in detail the scope of matters covered by the guidance, as well as the relevant legal background.
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.
