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.
The new article provides further clarifications regarding the clinical follow-up and supervision to be conducted by the parties responsible for clinical investigations.
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.
The new article highlights the aspects related to the key considerations related to the study design. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft...
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