The US FDA has removed N95s respirator masks from its medical device shortage list, citing increased domestic production.
When the COVID-19 pandemic first hit the US in March 2020, one of the first problems that became immediately clear was that there were not enough N95 protective masks to go around, especially for health care workers.
The shortage became even more serious as Americans were encouraged – and then mandated – to don protective face coverings in public.
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.
