The present article describes in detail the way the least burdensome approach should be applied. In particular, it explains the ideas behind the concept of the minimum information necessary. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
The article provides an overview of the regulatory requirements for monkeypox tests intended to address the public health emergency. In particular, the document describes the current situation with the virus and outlines special extraordinary measures FDA is going to...
The new article describes in detail the responsibilities of the regulating authority concerning the determination of risk associated with medical device studies; and also provides some examples illustrating the way the approach described in the guidance should be...
The new article highlights the aspects related to the main principles on which the least burdensome approach is based, and also describes the key points related to the said principles. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
The new article describes the responsibilities of institutional review boards (IRBs) when assessing clinical studies related to medical devices, as well as the approach to be applied when determining the regulatory status of such studies based on the risks associated...
The article provides an overview of key points and principles related to the least burdensome provisions. 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...