The new article describes in detail specific aspects related to the products placed on the market by virtual manufacturers and highlights the main points related to the responsibilities of all the parties involved in supplying medical devices in Ethiopia. ...
The new article addresses the aspects related to the post-approval stage, such as the validity of the certificates or changes thereto. Table of Contents The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document on infusion pumps. Table of Contents The document addresses the most important...
The Saudi Food and Drugs Authority (SFDA), a country’s regulating agency responsible for medical devices, has published guidance dedicated to the marketing authorization procedures for medical devices. The document highlights the most important rules and requirements...
It has been a tumultuous time for many CEOs and executives in America, from Martin Shkreli to John Stumpf and Heather Bresch. Their companies have been involved in high-profile tussles with Congress on issues including drug pricing, R&D costs, aggressive marketing...