The final recommendations from the FDASIA workgroup urge the government to focus regulatory attention on the highest risk products, while minimizing requirements for the large swath of health IT offerings that are lower risk. The recommendations, which largely align with a prior draft version, will inform a health IT regulatory framework proposal due to Congress in January.
A government-convened workgroup finalized its recommendations on a federal plan for regulating health information technology last week after four months of deliberation. HHS’ Health IT Policy Committee unanimously approved the recommendations at a Sept. 4 meeting.
The recommendations from the FDASIA workgroup urge the government to focus regulatory attention on the highest risk products, while minimizing requirements for the large swath of health IT offerings that...
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.
