Next FDA Commissioner May See Funding Freeze

House subcommittee chair says FY 2016 funding likely will be flat at best.

Stephen Ostroff and the eventual permanent replacement for FDA Commissioner Margaret Hamburg may not soon see dramatic agency funding increases.

Hamburg once again gave her pitch that FDA continues to be stretched by all its responsibilities during a March 4 hearing, but Republican appropriators seemed unmoved.

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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.