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Home » Certain Combo Products Can Qualify for PDUFA User Fee Waiver, FDA Says
Certain Combo Products Can Qualify for PDUFA User Fee Waiver, FDA Says
April 21, 2005
Combination product manufacturers can cut their application user fees by as much as 50 percent if their products qualify for the “barrier to innovation” waiver established by the Prescription Drug User Fee Act (PDUFA), according to an FDA guidance published in the April 21 Federal Register.