Biosimilar User Fee Collections Rise, But Little Spent On Program Costs

25 Apr 2016

FDA attributes large carryover balance to uncertainty in knowing when it has reached statutory funding threshold that triggers access to fees.

FDA spent more overall on the Biosimilar User Fee Act program in fiscal year 2015 but relied less on user fees.

In 2015, the agency had net fee collections of $22.8m under BsUFA but spent only $2.3m in fees to support the program, according to the agency's

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