In Case You Missed It: Top 10 "Gray Sheet" Stories 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.

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Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
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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.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 

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.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.