A Pediatric Advisory Committee meeting is planned for Sept. 14 to assess safety data for five devices used in children, and almost a dozen other drugs and biologics.
Five medical devices will be on the agenda Sept. 14 when US FDA's Pediatric Advisory Committee will gather for its latest meeting.
The committee is tasked with performing statutorily mandated pediatric-focused safety reviews for devices, drugs and biologics. The devices that will be reviewed next month are: Elana bv's Elana Surgical Kit;...
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.
