FDA commissioner says the agency cannot operate effectively without predictable budgets and that sequestering user fees needs to end.
FDA Commissioner Margaret Hamburg seems to have a similar problem with agency predictability as many in the industries she regulates.
Hamburg said the mandatory budget cuts known as sequestration have left her unsure of the funding that will be available for FDA, which is necessary for effective operations.
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.
