Where's The Beef? Trump Executive Order On Agency Transparency A Nothingburger For FDA, Lacks Teeth To Tackle True Guidance Doc Issues, Expert Says

President Trump signed an executive order on 9 October that aims for government agency transparency around guidance documents, enforcement, inspections and other areas. But longtime industry expert Steve Niedelman of the law firm King & Spalding says the order will have virtually no impact on how the US FDA conducts business. In fact, Trump's order does nothing to tackle legitimate gripes from industry around things like guidance docs.

 beautiful girl watching carefully the contents of her sandwich - Image

A new executive order from President Trump aims for government agency transparency around guidance documents, enforcement, inspections and other areas. But one longtime industry expert says the order will have virtually no impact on how the US Food and Drug Administration conducts business.

That's because the FDA already complies with most – if not all – of what's in the Executive Order on Promoting the Rule of Law Through Transparency and Fairness...

More from Regulation

More from Policy & Regulation

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

 
• By 

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.