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Drug Industry Daily
June 27, 2012 | Vol. 11 No. 126
Court Sides With Company on Generic Loophole for Product Fees, But PDUFA V Removes Exemption
A federal court has ruled that drugmakers shouldn’t have to pay product fees for drugs with an approved generic, even when that generic isn’t actively marketed, but this precedent will be short lived as the fifth authorization of the Prescription Drug User Fee Act (PDUFA) closes this loophole.
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