‘The Largest Reorganization In FDA’s History’: ORA Overhaul Better Thought Of As Agency-Wide Reorg

US FDA's response time and decision consistency on compliance issues should improve under reorganization that aims to take agency processes into the modern era. FDA is already moving forward on steps needed to implement the reorg as it awaits HHS and White House approval.

FDA-Alliance-reorganization-webinar
Senior FDA leadership detailed their vision for a planned FDA reorganization on 19 January. • Source: Screenshot from Alliance for a Stronger FDA webinar

A majority of US Food and Drug Administration units – 15 out of its 21 offices – will be impacted by a pending reorganization that is currently awaiting clearance from higher ups in the Biden administration, outgoing principal deputy commissioner Janet Woodcock said on 19 January.

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The European Commission has published a 44-page EHDS Q&A while industry has issued a joint paper emphasizing the importance of a stakeholder forum just as the EHDS Regulation is published and is due to enter into force.

HIMSS 2025: Interview with Aneesh Chopra, Arcadia’s Chief Strategy Officer, About The Future Of Health Data, Interoperability, AI

 
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HHS Buyout Offer Exempts FDA Reviewers And Inspectors

 

The $25,000 buyout, in addition to the early retirement program and layoffs, is intended to reduce the size of the US HHS workforce.