Drug Review Reorganization At US FDA Coming Into Focus
Oncology, neuroscience, and infectious diseases get acting directors as the expansion and renovation of the Office of New Drugs moves into Phase II.
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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.
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.
ODE I director Ellis Unger chafed at the notion of approving the Duchenne muscular dystrophy drug golodirsen on the same unvalidated surrogate marker, this time in the face of infection and renal toxicity concerns; OND’s Peter Stein granted Sarepta’s appeal while also calling attention to the company’s failure to timely conduct the eteplirsen confirmatory trial.