FDA's GDUFA War Chest Grows, And Industry May Look For Lower Fees

Two years into collecting generic user fees, FDA has more than $277 million in unspent dollars.

Industry has done a remarkable job funding FDA’s generic drug user fee program during its first two years, yet a large portion of the funds are not directly supporting ANDA approvals or facility inspections.

Net fee collections during fiscal years 2013 and 2014 were $624.9 million, exceeding estimates by more than $20 million. Yet,...

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