The new article provides additional details regarding the parental/guardian permission to be obtained before commencing an investigation, and also regarding the supporting data a study sponsor shall provide. Table of Contents The Food and Drug Administration (FDA or...
The new article highlights the key points to be taken into consideration with respect to endpoints in clinical studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
The new article highlights the main points related to the assessment of applicable risk, as well as the concept of direct benefit for study participants. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
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...