FDA
The document outlines the key points related to the Maltese regulatory requirements in the sphere of medical devices. In particular, the guidance addresses the matters associated with the fees payable by the parties responsible for medical devices intended to be...
FDA
The new article describes in detail the aspects related to the measurements to be performed in the course of clinical investigations for neonatal products, including the duration and timing. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the...
FDA
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...
COVID-19
The article provides an overview of the key provisions of the draft guidance documents dedicated to neonatal products. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
