Our most popular stories last month focused on tips from FDA experts on facility inspections, various legal trends, and Robert Califf's nomination to head FDA, among other topics.
"Gray Sheet" subscribers last month flocked mostly to stories that offered facility inspection tips, looks at legal trends and information on the latest nominee to lead FDA.
Two agency investigators urged manufacturers to take a deeper look at employee training challenges in a "Compliance Corner" feature, which attracted the most Web hits in September. Coming in second...
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.
