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

 
• By Sarah Karlin-Smith

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.

The reorganization, officially released in December 2023, has often been discussed as a revamp of the FDA’s food program and inspections work done by the Office of Regulatory Affairs division

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