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

Executive Summary

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.

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US Biosimilar Fee Collections Fall Short

A lower-than-expected number of fee-paying application submissions in FY 2018 resulted in the agency spending approximately $9.7m more than anticipated from its user fee carryover balance, leading to a reset of spend-down targets for the remainder of BsUFA II.

After Biosimilar Fee Collections Fall Short, US FDA Modifies Carryover Spend-Down Plan

A lower-than-expected number of fee-paying application submissions in FY 2018 resulted in the agency spending approximately $9.7m more than anticipated from its user fee carryover balance, leading to a reset of spend-down targets for the remainder of BsUFA II.

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