FDA
The new article provides further clarifications regarding requests for information as provided under the existing legal framework.
FDA
The article highlights the key points associated with the use-related risk analyses to be conducted with respect to various healthcare products intended to be marketed and used in the US.
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.
