FDA reveals $94m user fee increase

Share this article:
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).

Share this article:
close

Next Article in News

Email Newsletters

More in News

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi and partner Regeneron attached a $67.5-million priority review voucher to their experimental cholesterol drug alirocumab, making for a tighter race with Amgen.

HHS shows how diabetes adds up

HHS shows how diabetes adds up

A 2005-to-2010 survey shows diabetics 65-and-up juggle at least four co-morbid conditions and five medications for them.

AstraZeneca beefs up respiratory portfolio

AstraZeneca beefs up respiratory portfolio

AstraZeneca has made an $875-million move to beef up its respiratory pipeline by making Almirall's lineup its own.