FDA
The document highlights the key points related to the requests for information to be submitted 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.
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