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US FDA Biosimilar User Fee Collections, Expenditures Hit A High Point In 2017

 
• By Sue Sutter

For the first time since the biosimilar user fee program began, FDA spent more in fees than it collected, and more than it spent in appropriated funds.

US dollars

The most recent fiscal year was a financial turning point for the US FDA’s biosimilars user fee program, marking the first time the agency spent more in fees than it collected and more than it spent in appropriated funds for review activities.

The outlay was an early step in the agency’s planned spend-down of its user fee carryover balance under the second...

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