The Department of Justice may soon be busy with allegations of pandemic-related fraud and abuse, attorneys predicted in a recent conference presentation.
Don’t mistake a recent drop in False Claims Act (FCA) recoveries for lack of interest in pursuing medtech companies who flout the law, a group of attorneys cautioned at a 10 December conference hosted by the Food & Drug Law Institute.
As Reed Smith partner Sarah Cummings showed, the US Department of Justice collected just over $2bn in FCA recoveries in 2020 – a staggering amount that still fell short of...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
