Orphan, Combo, Pediatric Products Would See More Influence In Proposed US FDA Reorg
Reorganization also may force change to commissioner succession plan.
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Outgoing US FDA Commissioner Scott Gottlieb doesn't want a staff shakeup at the agency upon his departure. A look at near-term leadership strategies. Also, the wait time for confirmed commissioners has been trending down.
INFOGRAPHIC: Wait time for confirmed commissioner has been trending down.
Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.