US FDA Office Of New Drugs Reorg: Phase 3 Pushed To January
The FDA has confirmed the picks to head most of the new offices in the restructured drug review organization, with one notable exception. The choice for the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending, while one candidate – Hylton Joffe – will be serving as acting OND deputy director.
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Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.
Pharma companies and associations cite numerous examples of getting inconsistent advice across review divisions, including the number of clinical trials required for rare disease drugs and acceptance of innovative clinical trial designs and novel endpoints.
The move means Hylton Joffe can focus exclusively on his role as director of the Office of Rare Diseases.