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).
From the March 01, 2007 Issue of MM+M - Medical Marketing and Media
