Our analysis of survey data exploring how manufacturers respond to FDA Form-483 inspection reports was the most popular item on "The Gray Sheet" website
in October.
Our most popular stories last month focused on how device firms respond to FDA inspection reports; guidelines from the agency on how to handle manufacturing site changes; product labeling matters; and off-label marketing rules, among other topics.
Our analysis of survey data exploring how manufacturers respond to FDA Form-483 inspection reports was the most popular item on "The Gray Sheet" website
in October.
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.