Manufacturers can’t use the US FDA’s voluntary eSTAR product submission program for de novo requests until January – but they can start practicing now on how to use eSTAR for that review pathway.
The US Food and Drug Administration is prepping medical device manufacturers on how to make de novo requests via the agency’s voluntary eSTAR product submission program.
At present, the FDA’s electronic Submission Template And Resource – or eSTAR – template is reserved for companies making 510(k) submissions, but the agency will open up eSTAR to de...
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.
