US FDA's Stein To Sponsors: New Leadership From OND Reorganization Won't Change Your Development Plans
Office of New Drugs Director Peter Stein told sponsors during a panel discussion that they will be able to continue agreed upon development programs despite leadership changes arising from the OND reorganization; industry speakers excited, but also have some reservations, about the new OND.
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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.
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
CDER Director Woodcock announced that the drug center will soon launch the Drug Risk Management Board, which will coordinate product safety activities among the different offices; Patrizia Cavazzoni, who serves as CDER's deputy director of operations, will chair the board.