FDA
The final article of the cycle provides additional clarifications regarding certain specific aspects associated with the use of electronic records in the context of clinical investigations.
FDA
The new article provides further clarifications regarding the clinical follow-up and supervision to be conducted by the parties responsible for clinical investigations.
FDA
The new article describes in detail a specific approach to be applied when developing a follow-up plan.
FDA
The final article of the cycle explains the specific metrics to be measured in the course of clinical studies in order to collect accurate and reliable information regarding the products in question.
FDA
The new article clarifies the regulatory approach to be applied with respect to tailored responsive communication.
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