FDA plans to publicly issue its staff manual on scientific integrity in the near future.
FDA has developed new standards for scientific integrity in response to a White House initiative.
A December 2010 memorandum from the White House provided federal departments and agencies with guidance on how to create polices to ensure scientific integrity in their decision making.
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.
