North America
Ever wondered how to find the best predicate for your device, read on to find out more.
North America
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) proposed the withdrawal of two generic versions of Johnson & Johnson’s Concerta® marketed by Kremers Urban Pharmaceuticals, a subsidiary of the Lannett Company...
North America
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...
North America
As the benefits of software become increasingly present to healthcare systems, its risks do too. While software can increase the efficiency and effectiveness of healthcare, it can also create greater vulnerabilities. The medical device industry in particular has had...
North America
The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical devices require UDIs. The next phase of the system will be implemented...
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