The agency has agreed to accept Wright Medical’s PMA amendment for its embattled Augment bone graft, saving the firm from going to a dispute resolution panel this spring.
In a rare change of heart, FDA has agreed to accept Wright Medical Group NV’s PMA amendment with additional clinical data for its Augment bone graft instead of proceeding with a planned meeting of the agency’s dispute resolution panel, Wright announced March 10.
Wright said the PMA amendment, which the firm expects to submit around March 31, will include analyses of pre-existing radiographic films of clinical study patients before and after the procedure.
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.
