The US agency on 3 August said the webform should be used by manufacturers to report shortages of products deemed critical to fighting the ongoing COVID-19 pandemic.
The US Food and Drug Administration on 3 August announced a new online webform to make it easier for makers of medical devices deemed critical to fighting the ongoing COVID-19 pandemic to report product shortages.
The webform is “intended to further assist manufacturers in providing the FDA with timely and informative notifications about changes in the production of certain medical devices,” the agency says.
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.
