FDA reveals $94m user fee increase

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FDA drug and biologic user fees will jump almost 30% next year—from about $300 million to almost $400 million in 2008, according to details released about the PDUFA 4 negotiations.

The agreed-upon increase, which is yet to be submitted to Congress, directs $37.9 million to fund proposed enhancements to the PDUFA program.

The remaining amount is spread among a calculated “workload adjustment” for shortcomings not projected in the previous agreement ($20 million), increased costs for moving to its consolidated campus in White Oak, MD ($11.7 million), and an inflation adjustment ($17.7 million).

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