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FDA's Orphan Designation Backlog Plan Focuses On Efficiency, Not Staff

 
• By Derrick Gingery

No additional hiring is expected as US agency announces formal plan to return orphan review times to the original 90-day goal.

FDA entrance sign 2016

The US FDA will not add more staff to eliminate its backlog of orphan drug designation requests and return review times to the status quo.

An orphan designation makes a drug sponsor eligible for several incentives, including seven years of marketing exclusivity upon approval and tax credits for clinical trial costs. FDA's

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