The new article covers the aspects related to stratification for subject selection, as well as to site selection in the context of pivotal clinical investigations. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
The new article describes in detail the principle of necessity and the way it should be applied. The article also covers the aspects related to risk categories for interventions or procedures without a prospect of direct benefit. Table of Contents The Food and Drug...
The new article highlights the key points related to the study objectives and subject selection in the context of pivotal clinical investigations. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
The article provides an overview of the applicable regulatory requirements for ethical considerations in the context of clinical investigations of medical devices initially intended to be used for children. Table of Contents The Food and Drug Administration (FDA or...
The new article highlights the key points related to the principles for the choice of clinical study design, such as bias and variability and the way they can affect the accuracy and reliability of the results. Table of Contents The Food and Drug Administration (FDA...