FDA's Generic Drugs Office Faces Transition As Director Buehler Departs
Executive Summary
FDA'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
You may also be interested in...
GDUFA II: FDA Prefers A ‘Manageable Number of High-Impact Changes’
Negotiations for generic drug user fee reauthorization open with FDA saying it doesn't want a large number of small tweaks that will increase program complexity.
FDA Generics Office To Be Managed By Relative Unknown
Director Uhl’s medical leave puts bioequivalence office head John Peters in the limelight.
Growing Pains for Generic Drugs: OGD Gains Respect, But Loses Geba
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?