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

09 Oct 2019

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.

Road_Slow — US FDA's plan for spending down its biosimilar user fee carryover balance unexpectedly accelerated in FY 2018, forcing the agency to readjust. • Source: Shutterstock

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

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