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Latest From Kate Rawson
'Point/Counterpoint' program grew out of Assessment Aid initiative in the Oncology Center of Excellence and will be unveiled at an upcoming ODAC meeting.
US FDA's reorganization of drug reviews splits Keegan's old OHOP division into two.
Division directors are embracing the reorganization of US FDA's drug review operations.
Originally used for leadership positions, the alternative pay scale and a revamped hiring pilot are now shortening the time for FDA to onboard even technical staff, but the Office of New Drugs remains 'very understaffed.'
Shared review memorandum under Office of New Drugs reorg will help eliminate last-minute surprises between disciplines and provide greater consistency between divisions.
But US FDA is starting small, OCE Director Pazdur says. Program will hand-select approve high-priority oncology treatments that have to potential to change the standard of care.