New Faces In US FDA Review Division Leadership
Final phase overhaul of FDA's new drug review groups includes half-a-dozen first-time division directors. Most have long experience at the agency – but not all with the drugs they will now oversee.
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In a podcast interview, Janet Woodcock talks about review deadlines, prioritizing pre-approval inspections, and how advisory committees could be held in an era of social distancing.
Office of New Drugs Director Peter Stein said in an interview that a large amount of coronavirus-related work is arriving at the FDA, but so far staff are keeping up.
Hylton Joffe was named acting director of the new Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine but also will continue to serve as Office of New Drugs acting deputy director; agency veterans Ellis Unger and Julie Beitz also tapped for clinical office leadership roles in final stage of massive reorg.