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.

reorganization
The OND reorganization remains on track for completion in February or March.

The next phase of the US Food and Drug Administration’s roll-out of a new structure for its drug review operations will take place in mid-January.

Phase 3 of the four-stage roll-out had been tentatively scheduled to take effect 2 December. However, the FDA announced 25 November that it would pause the process until after the holidays, and Phase 3 is now set for 13 January

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