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GDUFA Fees Jump for 2014

Domestic FDF sites owe $220k to FDA

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has calculated the 2014 fees associated with the Generic Drug User Fee Amendments. A Federal Register filing — http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/pdf/2013-18625.pdf — revealed GDUFA’s inflation-based budget growth and its calculations for Facility Fees and other charges for 2014. The Federal Register did not provide an update on GDUFA’s progress in clearing ANDA backlog or facility inspections. For Final Dosage Form (FDF) manufacturers, which includes bot...

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