FDA's Generic Drugs Office Faces Transition As Director Buehler Departs
Executive SummaryFDA's Office of Generic Drugs is poised to enter a new era with new leadership, even as the agency is saying it will draw on the expertise of veteran officials for key initiatives
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FDA’s Office of Generic Drugs was at the start of a turnaround: $299 million in new user fees to clear a big ANDA backlog and fund overseas inspections, an elevated status within the Center for Drugs and a brand-new director to steer the ship. But there have been some bumps in GDUFA implementation, and OGD’s new director, Gregory Geba, has abruptly left the agency. What next for FDA’s generic drug oversight?