Australia
The new article addresses aspects related to the submission of the request for reconsideration and its subsequent review by the Minister. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
United States
The new article highlights aspects related to the clinical studies involving devices intended to treat opioid use disorder, namely, the importance of defining the patient population the device should be used for, and also the approach to be applied with respect to...
FDA
The new article highlights the aspects related to the determination of study duration, and also to the approach to be followed in order to mitigate the risks associated with missing data. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
Asia
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
Europe
The new article highlights aspects related to electronic submissions and specific types of products. Table of Contents The Swiss regulatory authority in the sphere of healthcare products (Swissmedic) has published a guidance document dedicated to the regulatory...
